Tongue evaluation system and method

ABSTRACT

An apparatus for evaluating the tongue strength and coordination of a subject includes an intermediate device such as a lever which is pivotably attached to a coupling device and extends into a cavity of a nipple element. The lever is detached from the nipple and pivotable in response to deformation of the nipple element by a tongue force exerted on the nipple element by a subject during a suck-swallow-breathe sequence. The coupling device includes a sensing device to wirelessly transmit sensor outputs to a mobile device paired to the sensing device. The sensing device includes at least one sealed chamber defined by a membrane and a sensor. In one example, a first membrane and sensor senses pressure change in a fluid in the apparatus, and a second membrane and sensor is actuated by the intermediate device to sense deformation of the nipple element. A method using the apparatus is provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. non-provisional applicationSer. No. 14/665,644 filed Mar. 23, 2015, U.S. non-provisionalapplication Ser. No. 14/166,281 filed Jan. 28, 2014 and issued as U.S.Pat. No. 8,986,229 on Mar. 24, 2015, U.S. non-provisional applicationSer. No. 13/479,640 filed May 24, 2012 and issued as U.S. Pat. No.8,663,131 on Mar. 4, 2014, U.S. provisional application 61/490,892 filedMay 27, 2011, and U.S. provisional application 61/578,004 filed Dec. 20,2011, which are each hereby incorporated by reference in their entirety.U.S. non-provisional application Ser. No. 14/665,644 is acontinuation-in-part of U.S. non-provisional application Ser. No.14/166,281 which is a divisional application of U.S. non-provisionalapplication Ser. No. 13/479,640 which is a non-provisional applicationof U.S. provisional application 61/490,892 and U.S. provisionalapplication 61/578,004.

TECHNICAL FIELD

The present disclosure relates to the field of biomechanics and morespecifically to the evaluation of tongue movement, strength andcoordination.

BACKGROUND

Measuring the movement, strength and coordination of an infant tongueduring sucking on the nipple of a bottle or pacifier presents severalchallenges including, for example, the limited oral space of the infantavailable for direct measurement and alteration of motor controlfeedback mechanisms induced at the tongue interface, the limited amountof space available for instrumentation of the nipple, alterationsrequired for instrumentation of the nipple which could affect naturalfeeding patterns, and obtaining accurate and precise measurements oftongue contact with the nipple interface. There are two stages offeeding where the tongue is applied to the nipple. During one stage,compression (squeezing) of the nipple by forces exerted on the nipple bythe tongue compresses the nipple against the palate. In a nutritivesucking condition, a volume of fluid present in the nipple is pushed outof the nipple and into the oral cavity due to compression of the nipple.In the other stage, with the oral cavity sealed, the jaw and tongue dropdown and away from the palate, enlarging the oral cavity and creatingnegative intra-oral suction. In a nutritive sucking condition, fluid isdrawn (sucked) out of the nipple. Both stages are essential to infantfeeding.

Adaptations to tongue muscle including decline of or lack of improvementin tongue strength and coordination may occur in premature infants whoare artificially fed for a period of time. Using animal models,researchers have documented significant negative changes in tonguemuscle responsiveness as a result of artificial feeding of newborn rats,which result in long term difficulties with feeding. As many as forty toseventy percent of premature infants exhibit both immature and atypicalfeeding patterns and those requiring prolonged respiratory support andthose experiencing delayed oral feeding are most often affected. Becauseartificial feeding of premature infants may not be avoidable,determining whether tongue force is adequate for safe, efficient oralfeeding, and developing interventions that lessen or eliminate anynegative impact on the tongue muscle, such as interventions forstrengthening the tongue during non-nutritive suck (NNS) and nutritivesuck (NS), are necessary. Clinical use of NNS with preterm infants topromote oral feeding is well documented. Indications are that NNSintervention has a positive impact on transition from tube feedings tooral feedings, improves bottle feeding performance and decreases lengthof stay. Volume intake, number of tube feedings prior to reaching fulloral feeds, and impact on growth and weight gain are outcomes that havenot been positively associated with NNS, and the impact of NNS on otherimportant oral feeding outcomes is not clear. Current measurement andevaluation methods are subjective in nature and provide limitedempirical evidence relative to assessment of infant feeding andswallowing.

SUMMARY

A system, method and apparatus to noninvasively evaluate movement,strength and coordination of the tongue of a subject is provided. Theapparatus for evaluating the movement, strength and coordination of thetongue of a subject includes a coupling device including a couplingelement. The coupling element includes a wall defining a passage. Thewall defines a passage opening in communication with the passage andfurther defines an aperture in communication with the passage. Thecoupling element includes a coupling end configured to receive a nippleelement such that the passage is in fluid communication via the passageopening with a nipple cavity defined by the nipple element. A sensorplug of the device encloses and seals the aperture. The coupling elementincludes a receiver disposed in the passage. The device further includesa lever defining a lever end. The lever is pivotably attached to thereceiver at a pivot point such that the lever end extends out of thepassage via the passage opening and extends into the nipple cavity andsuch that the lever end is detached from and in contact with a nipplesurface defining the nipple cavity. Deflection of the lever end causesan actuator defined by the lever to actuate movement of the sensor plug.The lever end is deflectable by deformation of the nipple element suchthat the movement of the sensor plug corresponds to the deformation ofthe nipple. Deformation of the nipple element exerts a deformation forcevia the nipple element to deflect the lever end. The actuator is incontact with the sensor plug such that the sensor plug exerts aresistive force via the lever end. Movement of a tongue of a subject,for example, during a suck-swallow-breathe cycle of a feeding session,exerts a tongue force on the nipple element such that deformation of thenipple element occurs by movement of the tongue of the subject, and suchthat movement of the sensor plug corresponds to at least one of themovement of the tongue and the tongue force.

Measurements of tongue movement and/or the tongue force can be used todetermine tongue strength and tongue coordination parameters of aninfant subject, including tongue force applied to a nipple duringnon-nutritive suck (NNS) and nutritive suck (NS). An intervention methoddirected at increasing NS tongue strength and coordination as well asNNS tongue strength and coordination of a subject with the intendedoutcome of positively impacting transition from tube feedings to oralfeedings by improving bottle feeding performance of the subject isprovided. The system, method and apparatus are configured to obtaindirect measurement of the force of the tongue on the nipple interface ina noninvasive manner and to evaluate kinetic changes to the nippleduring NNS and NS measurement by measuring tongue movement. Themagnitude and direction of forces applied by the tongue to the nipplecan be calculated through a calibration process of the evaluationapparatus and kinematic analysis of the applied forces such thatmeasurements of tongue strength, work, impulse, and power or otherderivations of force and time may be calculated from movementmeasurements obtained using the evaluation apparatus described herein.

Movement measurements obtained using the apparatus may be used tocalculate tongue force and derive tongue strength parameters and toevaluation tongue coordination. The evaluation apparatus includes anintermediate device, configured to be positioned within a nipple elementand to provide an output in response to deformation of the nippleelement by a deformation force exerted on the nipple element by thetongue of a subject during a sucking event. The output may be aresistive force exerted by the lever end of the intermediate deviceagainst the tongue of the subject during the sucking event, a movementmeasurement of the deformation force exerted on the nipple elementduring the sucking event, a pressure measurement corresponding to achange in fluid pressure of the fluid in the feeding apparatus, or acombination of these. The resistive force may be known or determined bycalibration. The movement measurement output may be calibrated to thedeformation or deformation force. The sucking event may be a nutritivesucking event wherein a fluid may be provided to the subject via thenipple element and the fluid may be in contact with the insert duringthe nutritive sucking event such that the nutritive sucking (NS)capability of the subject may be evaluated. The evaluation apparatus maybe configured for non-nutritive sucking such that the non-nutritivesucking (NNS) capability of the subject may be evaluated.

The intermediate device in one example is configured as a leverincluding a lever end which is in contact with, but not attached to, theinner surface of a nipple element, such that the lever is pivotablerelative to a pivot point established by pivotably attaching the leverto a coupling device sealably attached to the nipple element, bydeformation of the nipple to provide an output which is a movementmeasurement of the deformation force exerted on the nipple element by asubject during the sucking event. The nipple element may have a knowncompliance to provide an output which is a resistive force exerted inopposition to the deformation force and/or against the tongue of thesubject during the sucking event. A compliance element such as a sensormembrane in contact with the lever, e.g., in contact with theintermediate device, may output a resistive force exerted in oppositionto the deformation force exerted by the tongue of the subject, such thatthe effective or total resistive force exerted against the subject'stongue during an evaluation session, e.g., during a suck-swallow-breathecycle of the evaluation session, is defined by the combination of thecompliance of the nipple element and the compliance of the complianceelement, e.g., the sensor membrane exerting a membrane force on theintermediate device, e.g., on the lever.

The evaluation apparatus includes a coupling device configured to beoperatively connected to a nipple element, to position the insertrelative to the nipple element and/or receive the movement measurementoutput provided by the insert. The coupling device includes a housingassembly which contains a sensing device. The housing assembly may alsobe referred to as an SSB sensing device, where SSB as that term is usedherein refers to the suck-swallow-breathe cycle performed by a subjecton a nipple, which may be a NS nipple or a NNS nipple such as apacifier. The housing assembly is uniquely identified to an individualsubject and is configured for reuse with that individual subject, suchthat data transmitted by that housing assembly can be identified to thatindividual subject and stored and analyzed to develop a data history forthat individual subject. The coupling device includes a couplingassembly, which in the example described herein is a single useassembly, e.g., is non-usable such that a new coupling assembly isrequired for each feeding session conducted with an individual subject.The coupling assembly is removably attached to the housing assembly, andis configured to be sealably attached to a nipple element at a first endand to a container at a second end to provide a sealed apparatus chamberpartially defined by a passage of the coupling assembly, to containfluid in fluid communication with the nipple element. The intermediatedevice is positioned within the passage of the coupling assembly andpivotably attached therein such that the intermediate device, e.g., thelever, is in contact with the liquid in the passage during the suckingevent.

In one example, the coupling device includes a wall defining a passageand an aperture in communication with the passage. A sensor plug isoperatively attached to the wall to enclose and seal the aperture. Areceiver is disposed in the passage, and an intermediate deviceconfigured as a lever is pivotably attached to the receiver at a pivotpoint. The lever defines a lever end, and a tail end. The pivot point isintermediate the lever end and the tail end. Deflection of the lever endcauses an actuator defined by the lever to actuate movement of thesensor plug. The actuator is in contact with the sensor plug. The sensorplug is intermediate a sensor and the passage, where the sensor isconfigured to sense movement of the sensor plug and to generate a sensoroutput corresponding to the movement of the sensor plug by the actuator,where the sensor output is correlated to the deflection of the leverend.

In another example, the coupling device includes a wall defining apassage and an aperture in communication with the passage. A sensor plugis operatively attached to the wall to enclose and seal the aperture anddefines a membrane. The membrane is movable such that a change in afluid pressure of a fluid in the passage actuates a movement of themembrane corresponding to the change in the fluid pressure. The membraneis intermediate a sensor and the passage, where the sensor is configuredto sense movement of the membrane and to generate a sensor outputcorresponding to the movement of the membrane, where the sensor outputis correlated to the fluid pressure of the fluid in the passage.

A system for evaluating the strength of the tongue of a subject during asucking event is provided. The system includes the evaluation apparatusin secured and preferably wireless communication with a mobile devicehosting an evaluation application. The mobile device is in communicationwith a web portal configured to administer the evaluation system,including administering security protocols, storing data received fromthe evaluation apparatus via the mobile device, associating the datawith a subject and providing data analysis and history for each subjectpaired with a housing assembly, e.g., paired with a sensing device of anevaluation apparatus. A method for evaluating the strength of the tongueof a subject using the evaluation system is also provided.

The above features and advantages and other features and advantages ofthe present invention are readily apparent from the following detaileddescription of the best modes for carrying out the invention when takenin connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic side view of a tongue evaluation apparatusincluding a coupling device;

FIG. 2 is a schematic cross-sectional view of the tongue evaluationapparatus of FIG. 1 including the coupling device;

FIG. 3 is a schematic cross-sectional view of a nipple element shown ina sucking condition;

FIG. 4 is a schematic perspective illustration of another embodiment ofa tongue evaluation apparatus including a coupling device;

FIG. 5 is an exploded perspective view of the tongue evaluationapparatus of FIG. 4;

FIG. 6 is an exploded perspective view of the coupling device of FIGS. 4and 5 including a coupling element, a pivotable insert and a sensorplug;

FIG. 7 is a partial cross-sectional view of the evaluation apparatus ofFIGS. 4 and 5 including a sensing device and showing the pivotableinsert pivoted to a first position;

FIG. 8 is a cross-sectional view of the coupling device of FIG. 7showing the pivotable insert pivoted to a second position;

FIG. 9A is a schematic partial view of FIG. 7 showing the sensingdevice;

FIG. 9B is a schematic partial view of FIG. 7 showing the pivotableinsert actuating the sensing device;

FIG. 10A is a schematic top view of the coupling element;

FIG. 10B is a schematic side view of the coupling element;

FIG. 10C is a schematic cross-sectional view of section 10C-10C of thecoupling element;

FIG. 10D is a schematic cross-sectional view of section 10D-10D of thecoupling element;

FIG. 10E is a schematic view of the coupling element of FIG. 10Cincluding the pivotable insert;

FIG. 10F is a schematic view of the coupling element of FIG. 10Dincluding the pivotable insert;

FIG. 11A is a schematic perspective view of the sensor plug;

FIG. 11B is a schematic side view of the sensor plug of FIG. 11A;

FIG. 11C is a schematic top view of the sensor plug of FIG. 11A;

FIG. 11D is schematic cross-sectional view of the sensor plug showingsection 11D-11D of FIG. 11C;

FIG. 11E is a partial schematic view of section 11C of the sensor plugshown in FIG. 11D;

FIG. 12A is a schematic perspective view of the housing assembly ofFIGS. 4 and 5;

FIG. 12B is a schematic exploded view of the housing assembly of FIG.12A including a housing, a sensor assembly and a housing cover;

FIG. 12C is another schematic exploded view of the housing assembly ofFIG. 12A;

FIG. 13A is a schematic perspective view of the housing of FIG. 12A;

FIG. 13B is a schematic end view of the housing of FIG. 13A;

FIG. 13C is a schematic cross-sectional view of section 13C-13C of thehousing of FIG. 13B;

FIG. 13D is a schematic cross-sectional view of section 13D-13D of thehousing of FIG. 13C;

FIG. 13E is a schematic cross-sectional view of section 13E-13E of thecoupling device;

FIG. 14 is a schematic perspective view of the evaluation apparatus ofFIG. 4 in a first tilted position and in a second tilted position;

FIG. 15 is a schematic illustration of a system for evaluating tonguemovement including the evaluation apparatus of FIG. 4 and a mobiledevice;

FIG. 16 is a schematic illustration of an exemplary display generated bythe mobile device of FIG. 15; and

FIG. 17 is a schematic flow diagram of a process for evaluating thetongue movement and/or tongue strength of a subject using the system ofFIG. 15.

DETAILED DESCRIPTION

A system, method and apparatus for noninvasive evaluation of tonguemovement, tongue strength and/or tongue coordination, for example,infant tongue movement, strength and coordination during nutritive suck(NS) and non-nutritive suck (NNS), are provided. The system and methodmay include an intervention directed at training the tongue movement andincreasing NS tongue strength and coordination and/or NNS tonguestrength and coordination of a subject with the intended outcome ofpositively impacting a transition from tube feedings to oral feedings byimproving bottle feeding performance of the subject. The system, methodand apparatus are configured to enable noninvasive direct measurement ofthe force of the tongue on the nipple interface and kinematic changes tothe nipple during non-nutritive suck and nutritive suck and movementmeasurement. Broadly, the system, method and apparatus compriseproviding deformable materials which may be associated with sensors,allowing measurement of the movement of the tongue and degree ofdeformation of the deformable materials, the amount of force induced,etc., such as during application of force by the tongue during sucking.Without intending any limitation, the deformable materials may beconfigured as or associated with a nipple shape of known configuration,such as an infant bottle nipple, a pacifier nipple, and the like. Thesensor or sensors may be calibrated such that signals provided by thesensors over time may be collected and analyzed to identify stages ofthe feeding process and to determine the magnitude and direction offorces applied by the tongue of a subject to the nipple and kinematicanalysis of the applied forces may be performed to derive the power,impulse, and work performed by the tongue, and other measurements oftongue strength which may be derived from the sensor signals.

As used herein, “nutritive suck” refers to the process of a subject(“subject”) feeding with a bottle or breast and receiving fluid.Therefore, a “nutritive suck” (“NS”) condition is one where the nippleelement and/or the apparatus including the instrumented nipple isconfigured such that liquid is passed through the nipple to the subject,during a sucking event. For example, the NS nipple may define a nippleaperture through which liquid in communication with the nipple aperture,which may be liquid in a bottle or other container to which the NSnipple is fluidly attached, flows through the nipple into a subject'soral cavity during a sucking or feeding event. In nutritive suck thefluid is typically a substance ingested by the infant during feeding,such as infant formula, water, milk, etc. As used herein, fluid type isnot meant to be limiting.

As used herein, “non-nutritive suck” refers to the process of a subjectperforming the same task as nutritive feeding but not receiving fluid. A“non-nutritive suck” (“NNS”) condition is one where liquid is not flowedthrough the nipple, e.g., no feeding occurs. The nipple in NNS maycontain a nipple aperture for passage of fluid or may be sealed. In anon-limiting example, a NNS nipple may be configured without a nippleaperture such that fluid flow through the nipple is prevented. Inanother example, a NNS nipple may be configured as a pacifier. Inanother example, an evaluation apparatus may include a nipple with anipple aperture which may be used in either of a NS (liquid provided)condition or NNS (no liquid provided) condition.

As used herein, an “instrumented nipple” is a nipple element including,attached to or in selective communication with an insert, where theinsert may include one or more of a compliance element, a sensor, and anintermediate device. As used herein, “compliance” is a nipple or nippleelement's tendency to resist deformation caused by applied forces, forexample, the forces applied by the subject's tongue against the nippleduring sucking, and a “compliance element” is an insert configured tomodify the compliance of an instrumented nipple including the complianceelement relative to a nipple element which is not instrumented. As usedherein, “tongue strength” refers to a singular measure or plurality ofmeasures used to assess the ability of the tongue to perform itsfunction. Tongue strength measures include but are not limited to force,impulse, power and work. As used herein, “tongue coordination” refers tosingle measure or plurality of measures uses to assess the temporalfunctions of neuromuscular control or strength measures including butnot limited to frequency, variation or timing of sucking events.

Referring to the drawings wherein like reference numbers represent likecomponents throughout the several figures, the elements shown in FIGS.1-17 are not to scale or proportion. Accordingly, the particulardimensions and applications provided in the drawings presented hereinare not to be considered limiting. FIGS. 1-2 show a schematicillustration of an example configuration of a tongue evaluationapparatus 100 indicated generally at 100D and including a couplingdevice 90 and an instrumented nipple 10. FIGS. 4-13E show anotherexample configuration of a tongue evaluation apparatus 100 indicatedgenerally at 100E and including a coupling device 90 and instrumentednipple 10. The tongue evaluation apparatus 100 may be referred to hereinas an evaluation apparatus 100. As used herein, a “subject” is thesubject whose tongue movement and/or tongue strength and coordination isbeing evaluated by the evaluation apparatus 100. The subject may be aninfant, non-infant child, or adult subject who participates as thesubject of an evaluation session, also referred to herein as a feedingsession, where the subject receives the nipple element 11 into thesubject's oral cavity and it is the subject's tongue which exerts adeformation force on the nipple element during the evaluation session.As used herein, a “user” is a person using the evaluation apparatus 100to evaluate the tongue movement and/or tongue strength and coordinationof the subject, and who may, for example, perform one or more activitieswith the evaluation apparatus 100 such as assembly, set-up, calibration,and operation of the apparatus 100, including instructing the subjectand/or, for example, with an infant subject, conducting the evaluationsession by feeding the subject using the evaluation apparatus 100. Auser may be, by way of non-limiting example, a clinician, a medicalpractitioner, a feeding therapist, a parent, a caregiver, etc. The usermay be an individual sufficiently trained in the operation of theevaluation apparatus 100 to establish a communication link between theevaluation apparatus 100 and a mobile device 159 and conduct anevaluation feeding session, such that data collected during the feedingsession can be transmitted via the mobile device 159 to a clinician,etc. for remote evaluation of the condition of the subject.

The instrumented nipple 10 includes a nipple element 11 and anintermediate device 37 disposed in a nipple cavity 19 defined by thenipple 11. Referring to FIG. 3, shown is a schematic cross-sectionalview of the nipple element generally indicated at 11. The nipple element11 is shown in a sucking condition, e.g., in a deformed condition causedby a deformation force exerted on the nipple 11. The deformation forcemay be a tongue force FT exerted by a subject on the nipple element 11during sucking or during a feeding session conducted with the subjectusing the evaluation apparatus 100, or a calibration force FC exertedduring a calibration process to calibrate the evaluation apparatus 100,as described herein. The nipple element 11 is formed of a deformablematerial such as silicone, rubber, or other polymeric or naturalmaterial.

The nipple element 11 may be a standard nipple, e.g., a nippleconfigured as a pacifier or feeding nipple, also known as a bottlenipple, which is available over the counter. In a non-limiting example,the nipple element 11 may be configured for use with an infant. Thenipple element 11 may be configured as a non-infant (non-infant child oradult) pacifier and may be instrumented to provide an instrumentednipple 10 for use in evaluating the tongue movement, tongue strength,tongue coordination, and/or swallowing capabilities of a non-infantsubject, for example, an elderly subject. In this example, the non-childnipple element 11 may be configured for either NS or NNS and adaptableto a fluid source or as otherwise described herein to enable evaluationof the subject's swallowing capability. It would be understood based onthese examples that the configuration of the nipple 11 element shown inthe figures is not intended to be limiting, and the nipple element 11may be of a standard (over the counter) configuration or a non-standard(customized) configuration. The nipple element 11 may be referred toherein as an unmodified nipple or as a non-instrumented nipple, in whichcase that the nipple element 11 refers to a standard nipple element,e.g., a nipple element, bottle nipple, etc. which has not been modifiedfrom its standard configuration or the nipple element 11 withoutinstrumentation. A nipple element 11 may be combined with one or moreinserts, as described in further detail herein, to provide aninstrumented nipple 10.

In a typical configuration, the nipple element 11 includes a tip portion14 at one end and a flange portion 15 at the opposing end. The tipportion 14 is adjacent the intermediate portion 13 of the nipple, alsoreferred to herein as the nipple body 13. A base portion 12 isinterposed between the body 13 and the flange portion 15. The nippleelement 11 shown in FIG. 3 is configured as a nutritive suck (NS)nipple, such that the the nipple wall 16 defines a nipple cavity 19which is open at the tip 14 via a nipple aperture 25, and is open at theopposing end via an opening 18 defined by the flange portion 15. In anon-limiting example, the nipple element 11 may be configured as apacifier and may include, as shown in FIG. 2, an extension 27 providedas a handle for inserting, positioning and removing the nipple element11 relative to a subject's oral cavity. In the example shown in FIG. 2,the extension 27 is received into the cavity 94 of the coupling device90. The subject's oral cavity may also be referred to herein as thesubject's mouth.

The nipple element 11 is shown FIG. 2 in a first condition, which mayalso be referred to herein as a resting or non-deformed condition. Inthe resting condition, minimal to no forces are exerted by the tongue onthe nipple element 11 such that deformation of the nipple element 11 isminimal to none. A nipple element 11 is shown in FIG. 3 in a secondcondition, which may also be referred to herein as a sucking or deformedcondition. In the sucking condition, the nipple is positioned in thesubject's mouth such that a first portion 20 of the nipple element 11 isin contact with the subject's palate (not shown), and a constrainingforce FP is exerted by the palate against the first portion 20, whichmay be referred to herein as the palate facing portion of the nipple.During sucking, the subject's tongue (not shown) exerts a tongue forceFT on a second portion 21 of the nipple element 11, as shown in FIG. 3.The second portion 21 may be referred to herein as the tongue facingportion 21 of the nipple element 11 and generally opposes the palatefacing portion 20 when the nipple is positioned in the subject's mouth.In a sucking condition, as shown in FIG. 3, the tongue force FTcompresses the nipple element 11 by deforming the nipple wall 16 of thetongue facing portion 21 toward the palate facing portion 20. Themagnitude of the deformation in the sucking or deformed condition may bemeasured by a deformation distance D, as shown in FIG. 3. It would beunderstood that the deformation distance D of the nipple in the restingcondition shown in FIG. 2 is zero.

The nipple element 11 exerts an effective resistive force FR inopposition to the tongue force FT. The effective resistive force FR isat least partially a function of the compliance of the nipple element11, where the compliance of the nipple element 11, as that term is usedherein, is the tendency of the nipple element 11 to resist deformationcaused by applied forces such as the tongue force FT. The compliance ofthe nipple element 11 and the resistive force FR may be determined byone or more factors, including but not limited to the materialcharacteristics of the nipple element 11, such as the material type,elasticity, hardness, etc. of the nipple element 11, and the wallthickness W of the nipple wall 16. The effective compliance of thenipple 10 (including the nipple element 11) and the effective resistiveforce FR exerted on the tongue of the subject may be modified bychanging the configuration of the nipple wall 16 in the tongue facingportion 21 and/or adding a compliance element 80 configured to exert aresistive force in opposition to a tongue force FT, where in thisinstance, the effective resistive force FR is partially defined by thecompliance of the nipple element 11 and partially defined by theresistive force exerted by the compliance element 80. Instrumentednipples 10 of varying compliance and resistive force FR may be used inan intervention method as shown in FIG. 14 to develop tongue strengthand coordination in a user subject such as an infant, which may be apreterm infant.

Deformation forces exerted on a nipple in a sucking condition can beevaluated by instrumentation of the nipple element 11 using an insertincluding or configured as a sensing device, such as but not limited toa sensing device 30 described in further detail herein and illustratedby the figures, to provide an instrumented nipple 10. The complianceand/or resistive force of a nipple may be modified by instrumentation ofthe nipple element 11 using an insert including or configured as acompliance element 80 having a known compliance and resistive force FR,such as but not limited to a compliance element 80 to provide aninstrumented nipple 10. The known compliance and/or resistive force FRmay be determined by configuration of the instrumented nipple 10 or bycalibration of the instrumented nipple 10 using a calibration apparatusas described in U.S. non-provisional application Ser. No. 13/479,640filed May 24, 2012 and issued as U.S. Pat. No. 8,663,131, incorporatedherein in its entirety. The term “instrumented nipple,” as used herein,refers to a nipple element 11 including, in contact with, or inoperative communication with at least one insert, where the insertcomprises one or more of an intermediate device 37, a sensing device 30,a compliance element 80, with the insert configured to directly measurethe deformation force exerted on the nipple element 11 and/or to providean instrumented nipple 10 characterized by a known effective complianceor calibrated resistive force FR, where the effective compliance is atleast partially defined by the compliance of the nipple element 11.

As shown in FIG. 2, the coupling device 90 includes a sensing device 30configured to measure deformation of the nipple element 11. In oneexample the sensing device 90 includes an optical sensing device tomeasure the deformation of the nipple element 11. In another example,shown in FIG. 2, the coupling device includes an intermediate device 37disposed in the nipple cavity 19 and in communication with the sensingdevice 30, such that the intermediate device 37 detects deformation ofthe nipple element 11 and actuates the sensing device 30 to sense orotherwise measure the deformation. In the example shown in FIG. 2, theintermediate device 37 is configured as a cantilever element affixed ata first end 38 to coupling device 90 via at least one of the receiver 96and the sensing device 30, such that the cantilever element is inoperative communication with the sensing device 30, and the free(non-affixed) end opposing the attached end 38 is positioned within thenipple cavity 19 adjacent the inner surface 17 of the nipple element 11such that the free end of the cantilever is adjacent to but detachedfrom the nipple element 11 and the free end of the cantilever ismoveable in response to deformation of the nipple element. Deflection ofthe free end of the cantilever in response to movement of the nippleelement resultant from the deformation force exerted on the nippleelement 11 is transmitted via the cantilever element, e.g., via theintermediate device 37 defining the cantilever element, to the sensingdevice 30. The sensing device 30, in this example, may include a lineardisplacement sensor in communication with the cantilevered intermediatedevice 37 to sense the displacement (deformation change) of thecantilevered intermediate device 37 and provide an output in response tothe displacement (deformation change).

The example shown in FIG. 2 of an intermediate device 37 defining acantilever is non-limiting, and it would be understood that otherconfigurations of an intermediate device 37 may be used to generate anoutput in response to movement of the nipple element resultant from adeformation force exerted on the nipple element, where the deformationforce may include, as shown in FIG. 3, a tongue force FT exerted on thenipple element 11 by the tongue of a subject during a sucking event. Byway of non-limiting example, the intermediate device 37 may include oneor more of, and/or be configured as one or more of a triggering device,a connector, a mechanical pulley or cam system, a pivotable lever, apivot, an electrical, pneumatic, magnetic, hydraulic or optical switch,a sensor, a cantilever, and/or an actuator, which is positioned in thecoupling device 90 relative to the nipple element 11 to output aresponse to deformation of the nipple element 11. The output may bemeasurable as a force, displacement, magnetic property, pressure,optical characteristic, etc. as defined by the configuration of theintermediate device 37. In one example, the intermediate device 37 mayinclude a piezoelectric material configured to sense deformation changesin a compliance element 80 position on or adjacent to the nipple element11. The intermediate device may be in communication with the sensingdevice 30 and/or a data collector/analyzer, such that the intermediatedevice when actuated by the deformation change of the compliance element80 transmits or transfers the deformation change to the sensing device30 and/or to the data collector/analyzer, as an output, where the outputmay be in the form of an electrical, magnetic, sound, optical, orpneumatic signal, a displacing force, stress or strain provided as aninput to the sensing device 30 or the data collector/analyzer. The datacollector/analyzer may be included in a mobile device 159 incommunication with the sensing device 30, as illustrated by the tongueevaluation system 105A shown in FIG. 15. In another example, shown inFIGS. 4-7, a sensing device 30 is in communication with an intermediatedevice 37, which is partially disposed in the nipple cavity 19 toprovide an instrumented nipple 10, and which is pivotably mounted suchthat when the nipple element 11 is deformed, the intermediate device 37pivots to cause an actuator 74 to actuate the sensing device 30, suchthat the sensing device 30 senses or otherwise measures deformation ofthe nipple element 11.

The tongue evaluation apparatus 100 may be calibrated such that theoutput provided by the intermediate device 37 in response to deformationof the nipple element 11 by a known deformation force FT may bedetermined. The intermediate device 37 may be configured to provide aresistive force FR which may be known based on characteristics of theintermediate device 37, including the configuration of the intermediatedevice 37, the method of attaching the intermediate device 37 to thecoupling device 90, the inclusion of a compliance element 80 in theintermediate device 37 and/or acting on the intermediate device 37, thematerial, shape, dimensions, etc., of the intermediate device 37, and/orwhich may be determined by calibration. The response to the deformationforce FT by the intermediate device 37 is transmitted as an output tothe sensing device 30, thereby providing a means for direct measurementof the deformation force exerted on the nipple element 11 and/or theintermediate device 37, and/or evaluation of a subject's tonguemovement, strength and/or coordination when the deformation forceexerted on the nipple is the tongue force FT exerted on the nippleelement 11 of the evaluation apparatus 100 by the subject. By way ofnon-limiting example, an apparatus and method for calibration of theevaluation apparatus is described in U.S. non-provisional applicationSer. No. 13/479,640 filed May 24, 2012 and issued as U.S. Pat. No.8,663,131, incorporated herein in its entirety. Forces applied by thetongue during evaluation of a subject correspond to the followingequation:FT∝DT≅FC∝DC∝Nipple Compliance  (1)where FT are the forces produced by the tongue on an instrumented nipple10, DT is the distance the nipple deforms due to the tongue, FC are theforces applied to the instrumented nipple 10 during a calibrationprocedure to deform the instrumented nipple 10, where the distance thenipple deforms due to the calibration force are DC. An example of adeformation distance D is shown in FIG. 3, which is illustrative of thedistance DT the nipple element 11 is deformed by the tongue force FT ofa subject when deformation is caused by the subject's tongue during asucking event, and which is illustrative of the distance DC the nippleelement 11 is deformed upon imposition of a calibration force FC. Thesensing device 30 of the evaluation apparatus 100D, 100E may includepressure sensors 79A, 79B configured to detect changes in fluid pressureof fluid in the sealed apparatus chamber defined at least partially by apassage 97 of the coupling device 90, where the pressure in the sealedapparatus chamber is referred to herein as the fluid pressure. Duringcalibration, changes in fluid pressure within the sealed apparatuschamber may be measured by the calibration apparatus (not shown) andused to calibrate the sensing device 30. It would be understood thatcalibration may not need to be performed for every nipple or at everyinstance of use of the evaluation apparatus 100, for example, after aninitial calibration has been performed and/or when the properties of thevarious elements of the coupling device 90 and the nipple element 11 areestablished.

In the examples shown, the coupling device 90 includes a couplingelement 93 which forms the body of the coupling device 90. The couplingelement 93 is configured at a first end 91 to interface with a bottle 40defining a bottle cavity 41 (see FIG. 5). The bottle 40 may be astandard infant feeding bottle (baby bottle), e.g., one which isavailable over the counter. In one example, the first end 91 may definea plurality of threads for engaging the threaded end 42 (see FIG. 5) ofthe bottle 40, to create a sealed interface between the bottle 40 andcoupling device 90. The example provided herein is not limiting, andother configurations of the first end 91 may be used to create a sealedinterface between a container or bottle 40 and the coupling device 90.For example, the first end 91 may be configured to snap on, clip to, orcreate an interference fit with the container 40 to provide a sealedinterface. As shown in FIG. 6, a seal 116, which may be, for example, anO-ring or gasket, may be inserted between the bottle 40 and the couplingdevice 90 to provide a sealed interface between the bottle 40 and thecoupling device 90. The seal 116 is made of an FDA Class V1 “food safe”(FS) material, which in the non-limiting example shown is a silicone ornitrile (synthetic rubber) FS material.

The coupling element 93 is configured at a second end 92 to interfacewith a collar 28. The collar 28 may be, in the example shown, a standardinfant bottle collar or ring which is threadable onto the second end 92of the coupling device 90 to retain the nipple element 11 in sealingcontact with the coupling device 90. In one example, the second end 92may define a plurality of threads for engaging the collar 28, where theplurality of threads may be configured substantially similar to theplurality of threads of a standard infant feeding bottle. The couplingdevice 90, thus configured, is readily attachable to a standard infantfeeding bottle 40 and a standard bottle collar 28, where the term“standard” as used herein refers to an item which is readily availableto a consumer in a standardized format. In the present example, astandard infant feeding bottle is one which is available over thecounter, as that term is commonly understood. Likewise, a standardbottle collar is one which is available over the counter and isattachable to a standard infant feeding bottle, where it would beunderstood that the standard bottle collar and feeding bottle would haverespective threaded interfaces which are compatible or corresponding toenable attachment of the collar 28 to the bottle end 92.

In the example shown in FIG. 2, first end 91 of the coupling device 90defines a cavity 94 of sufficient depth to receive a nipple element 11including an extension 27. In a non-limiting example, the nipple element11 including the extension 27 may be configured as a standard, e.g.,over the counter pacifier, such as a Soothie® pacifier, such that theevaluation apparatus 100D may be assembled using the coupling device 90,an insert which may be at least one of a sensing device 30 and acompliance element 80, and a standard bottle 40, a standard collar 28and a nipple element 11, where the nipple element 11 may be a standardpacifier to provide an NNS configuration, or standard feeding nipple toprovide an NS or NNS configuration. In an NS configuration, fluid may beflowed from a bottle 40 connected to the first end 91 of the couplingdevice 90 through a cavity 97 defined by an inner wall surface 95 of awall 196 of the coupling element 93 and through a nipple aperture 25 ofthe nipple element 11. In the example shown, the cavity 97, which mayalso be referred to herein as a fluid passage 97, may be partiallydefined by the end cavity 94 defined by the second end 92 of thecoupling element 93. The example provided herein is not limiting, andother configurations of the second end 92 may be used to position thenipple element 11 relative to the coupling device 90 and/or to retainthe nipple element 11 in sealing contact with the coupling device 90.For example, the second end 92 may be configured with a recessed portionor groove into which the flange 15 of the nipple element 11 may beinserted or retained. The nipple element 11 may be configured to beextended over the second end 92 to create an interference fit with thecoupling device 90 to provide a sealed interface without requiring thecollar 28. The collar 28 may be configured to snap or clip onto thesecond end 92 or to otherwise be retained by the second end 92. Anotherexample configuration is shown in FIGS. 4-7, and described in additionaldetail herein.

In an NNS configuration, the evaluation apparatus 100D may be usedwithout a bottle 40. A plug (not shown) may be provided to enclose thefirst end 91 of the coupling device when used without a bottle 40, toprotect the threaded interface, prevent contamination of or damage tothe interior cavity 94 and/or to the fluid passage 97 of the couplingdevice 90, the receiver 96 or other components such as a sensing device30, etc. housed therein. The plug (not shown) may be configured tosealably attach to the first end 91, to provide a sealed apparatuschamber defined by combination of the plug, the wall 196 of the couplingelement 93, and the inner surface 17 of the nipple element 11.

As shown in FIGS. 1-2, the coupling device 90 may include a sensingdevice 30, an intermediate device 37, and/or a receiver 96 to receiveand transmit data and/or sensor signals to, for example, a datacollector/analyzer or a data storage device, which may be a portabledata storage or memory device such as a SIM card, flash drive, etc. orother portable device in communication with the coupling device 90 whichmay include RAM or flash memory and be used to transfer the collecteddata to the data collector/analyzer. The communications interface 35 maybe configured to transmit output signals from the sensing device 30 ofthe evaluation apparatus 100D, for example, by wirelessly transmittingthe sensor signals to the data collector/analyzer using any suitablemeans of wireless transmission such as Bluetooth®, Bluetooth® Low-Energy(BLE), RFID, Wi-Fi, ZigBee®. In the example shown in FIG. 15, thecoupling device 90 is in wireless communication via a communicationsinterface 35 with a mobile user device 159 using Low-Energy Bluetooth®,which is also known as Bluetooth 4.0®, Smart Bluetooth®, and/orBluetooth LE®. The mobile user device 159 in the example shown includesmemory 178, an evaluation application 188, a processor 192, and adisplay 175 for receiving, analyzing and displaying the output signalsreceived from the sensing device 30, as described in further detailherein. The evaluation application 188 and/or the processor 192 may beconfigured as a data collector/analyzer. The mobile user device 159,which may be referred to herein as the mobile device 159, may beconfigured as a laptop computer, notebook, a tablet, such as an iPad®, asmart phone, or the like.

The coupling device 90 may include a user interface 75, which mayinclude a display and/or input/output interface for visually, audibly,or textually communicating data, analysis results, messages,instructions, alerts, etc. The coupling device 90 may include atransducer 76, which may be configured, for example, to convert an inputsignal received from a sensing device 30, intermediate device 37,pressure sensor 79, into an output signal to be provided to thecommunications interface 35, stored in a memory 78, displayed via theuser interface 75, etc. The input signal may be an electrical,mechanical (force, stress, strain), electromagnetic, optical, chemical,pressure, or acoustic signal which may be converted by the transducer 76into an output signal which may be, in a non-limiting example, anelectrical, visual or audible signal. The coupling device 90 may includea power source 77, which may be a battery or power input interface, andmemory 78 configured as one or more of Read Only Memory (ROM), RandomAccess Memory (RAM), electrically-erasable programmable read only memory(EEPROM), etc., of a size and speed sufficient for executing thefunctions performed by the coupling device 90.

The coupling device 90 may include the receiver 96 which may beconfigured to position, connect to, and/or receive one or more of thesensing device 30, the intermediate device 37 or a holder 39. Thereceiver 96, in one example, may be in operative communication with oneor more of the communications interface 35, the user interface 75, thetransducer 76, and the memory 78 and may be configured to transmit dataand/or signals between the sensing device 30 and/or intermediate device37 and one or more of these. The sensing device 30 may be integratedinto the receiver 96 and/or coupling 90 as shown in FIG. 2, and outputsignals may be received via the intermediate device 37 in communicationwith the compliance element 80 and the integrated sensing device 30. Inanother example shown in FIGS. 4-7, the receiver 96 may be configured toreceive the intermediate device 37 and to position the intermediatedevice 37 relative to the nipple element 11 and the sensing device 30.In the example shown, the intermediate device 37 is pivotable in thereceiver 96 by deformation of the nipple 11, to actuate the sensor 79Bin the sensing device 30.

The coupling device 90 may include one or more sensors 79 incommunication with the cavity 94 and/or the fluid passage 97 defined bythe coupling device 90. One or more of the sensors 79 may be configuredas a pressure sensor. An apparatus chamber of the evaluation apparatus100 may be formed by the bottle cavity 41, fluid passage 97 and nipplecavity 19, such that the pressure sensor 79 in communication with thesealed apparatus chamber thus formed by the connected nipple cavity 19and fluid passage 97 can be used to measure pressure changes in thesealed apparatus chamber resultant from tongue movement of a subject,for example, during a sucking event, and the pressure measurements usedin evaluating the tongue movement and/or tongue strength andcoordination of the subject. Alternatively, the plug may be sealablyattached to the first end 91 of the coupling device 90 to form a sealedapparatus chamber defined by the nipple cavity 19 and the fluid passage97 to measure pressure changes in the sealed apparatus chamber thusformed, using the pressure sensor 79.

The tongue evaluation apparatus 100D including the coupling device 90may be assembled in various configurations and with various combinationsof sensing devices 30, compliance elements 80, intermediate devices 37,etc., including but not limited to the configurations shown in FIGS.1-13E. Referring to FIG. 2, the evaluation apparatus 100D includes anipple element 11 configured as a pacifier which is positioned insealing contact with the second end 92 of the coupling element 93, andretained in position by the collar 28, to provide an NNS configuration.In an NNS configuration, a bottle 40 or a plug may be optionallyattached to the first end 91 of the coupling element 93. Alternatively,a feeding nipple element 11 including a nipple aperture 25 (see FIG. 3)may be substituted for the pacifier nipple element to provide an NSconfiguration. In the NS configuration, a bottle 40 containing a fluid24 may be attached as shown in FIG. 1. An intermediate device 37including a compliance element generally indicated at 80 is positionedin the nipple cavity 19 to provide an instrumented nipple 10. Thecoupling device 90 includes an integrated sensing device 30 forreceiving signals from the compliance element 80 via the intermediatedevice 37 which is in operative communication with the complianceelement 80 and the integrated sensing device 30. In one example, theintermediate device 37 may be connected to the integrated sensing device30 via the receiver 96.

The holder 39 may be provided to support or position the intermediatedevice 37 and/or the compliance element 80 with respect to the nippleelement 11 and the receiver 96. The holder 39 may be integral to theintermediate device 37. The receiver 96 may be configured to receive theholder 39 in an oriented position relative to the nipple element 11,and/or tongue facing portion 21 of the nipple element 11. The receiver96 may be integral to the coupling element 93. The compliance element 80may be oriented or positioned to be deformed by and/or sense adeformation force exerted on the nipple element 11. The deformationforce may be a tongue force FT exerted on the tongue facing portion 21of the instrumented nipple 10 by a subject during a sucking event, suchthat noninvasive direct measurement of the deformation force FT may bemade using the evaluation apparatus 100D to evaluate the tonguemovement, tongue strength and coordination and/or sucking capability ofthe subject. In the example of the tongue evaluation apparatus 100Eshown in FIGS. 4-10F, the holder 39 is integral to and defined by theintermediate device 37 and includes a pivot element 99, also referred toherein as a pivot pin or a cross-pin, and a tail 67, which are received,respectively, into a fulcrum 166 and a tail slot 167 defined by thereceiver 96 of the coupling body 93, as described in additional detailherein.

Referring to FIGS. 4-14, an example configuration of a tongue evaluationapparatus 100E is illustrated. As shown in FIGS. 4-6, the evaluationapparatus 100E includes a coupling device generally indicated at 90. Thecoupling device 90 includes a housing assembly generally indicated at150 and a coupling assembly generally indicated at 190. The couplingassembly 190, as shown in FIG. 6, includes a coupling element generallyindicated at 93, a sensor plug generally indicated at 120, andintermediate device generally indicated at 37. The intermediate device37 is pivotably attached to the coupling element 93. As shown in FIGS.12A-12C, the housing assembly 150 includes a housing 140 and a cover 141operatively attached to each other, to house the sensing device 30 andthe communications interface 35 (see FIGS. 12B, 12C). When the housingassembly 150 is attached to the coupling assembly in an installedposition, the sensing device 30 and sensor plug 120 cooperate to providea sensing apparatus 130 including at least one sensor 79. In the exampleshown, the sensing device 30 includes a first sensor 79A to sensechanges in pressure within a fluid passage 97 defined by the couplingelement 93, and a second sensor 79B to sense movement of theintermediate device 37, for example, in response to pivoting of a leverend 69 of the intermediate device 37 positioned in a nipple element 11,where the lever end 69 is in contact with the inner surface 17 of thenipple element 11 and is pivoted by deformation of the nipple element 11by the tongue of a subject during a sucking event, and where pivotingthe intermediate device 37 actuates the sensor 79B, as described infurther detail herein.

The coupling element 93, shown in additional detail in FIGS. 7, 8 and10A-10F, includes the first end 91, the second end 92, and a centralportion 103 connecting the first and second ends. As described for FIGS.1 and 2, the first end 91 is configured to interface with a bottle 40defining a bottle cavity 41. The bottle 40 may be a standard feedingbottle, of the type that would be available over the counter. In theexample shown, the first end 91 may define a plurality of threads forengaging the threaded end 42 of the bottle 40. A seal 116, which may be,for example, an O-ring or gasket, may be inserted between the bottle 40and the coupling device 90 to seal the interface between the end 42 ofthe bottle 40 and the first end 91 of the coupling element 93. Thesecond end 92 of the coupling element 93 is configured to receive anipple element 11, which as previously described may be a feeding nippleor a pacifier. The nipple element 11 may be sealably retained to thesecond end 92, for example, by the collar 28 which may be threadablyengaged to the second end 92 of the coupling element 93. The fluidpassage 97 defined by the coupling element 93 is open at a first opening168 defined by the first end 91 and is open at a second opening 169defined by the second end 92 of the coupling element 93, such that fluidcan enter the first opening 168 from, for example, the bottle 40connected to the first end 91, and flow through the fluid passage 97 andout of the second opening 169 into cavity 19 of the nipple element 11sealably retained to the second end 92. As used herein, the term fluidis not meant to be limiting, and is not limited to one type of fluid.For example, the fluid flowing through the fluid passage 97 may be asubstance ingested by the infant during feeding, such as infant formula,water, milk, juice, etc. In a preferred example, the fluid is anon-compressible fluid.

The central portion 103 of the coupling element 93 includes an uppersurface 154 (as oriented in the figures and in operation of theevaluation apparatus 100E), also referred to herein as an aperture face154, which defines a plug aperture 155 to receive the sensor plug 120.The plug aperture 155 is further defined by an aperture lip 101surrounding the plug aperture 155 (see FIGS. 10A, 10C and 10E). Thefluid passage 97 is open at the plug aperture 155, such that the plugaperture 155 is in fluid communication with the fluid passage 97. Theplug aperture 155 is configured to receive the sensor plug 120 such thatthe sensor plug 120 is sealably attached to the aperture face 154 and tothe aperture lip 101, such that the sensor plug 120 encloses and sealsthe plug aperture 155 and prevents leakage of fluid from the fluidpassage 97 via the plug aperture 155 to the exterior of the couplingelement 93. The sensor plug 120 includes at least one membrane 126which, with the sensor plug 120 installed in the plug aperture 155, isin fluid communication with the fluid passage 97. In the example shown,the sensor plug 120 includes a first membrane 126A and a second membrane126B, both in fluid communication with the fluid passage 97, as shown inFIGS. 7-8. In use, the evaluation apparatus 100E is preferably filledwith a sufficient volume of non-compressible fluid, e.g., infantformula, water, milk, juice, etc., such that the passage 97 issubstantially filled with fluid during a feeding/evaluation session tofully submerge the membranes 126 of the sensor plug 120 when theevaluation apparatus 100E is tilted, e.g., tilted, at a feeding tiltangle β (see FIG. 14), where full submersion of the membranes 126contributes to the accuracy and repeatability of pressure measurementsmade by the evaluation apparatus 100E.

The central portion 103 of the coupling element is characterized by asmaller cross-section than the first and second ends 91, 92 of thecoupling element 93, such that the generally saddle-shaped housingassembly 150 can be positioned between the first and second ends 91, 92and removably attached to the central portion 103. In the example shown,the housing assembly 150 and the coupling element 93 are shaped suchthat with the housing assembly 150 attached to the coupling element 93,the coupling device 90 is generally cylindrical in shape, defining alongitudinal axis 117. The generally cylindrical shape of the couplingdevice 90 is advantaged by being ergonomically friendly, providing easeof grasping and holding the evaluation apparatus 100 by a user duringfeeding of a subject, and providing a compact wireless unit which can bepositioned between the bottle 40 and nipple element 11 without the needto connect to external devices during operation. The generallycylindrical shape of the coupling device 90 is not intended to belimiting, and it would be understood that other ergonomically friendlyand compact external shapes for the coupling device 90 may be used. Inthe example shown, the aperture face 154 defining the plug aperture 155and the adjacent side surfaces of the central portion 103 of thecoupling element 93 define a rectangular portion to interface with agenerally rectangular channel 142 defined by the housing 140 of thehousing assembly 150 (see FIG. 9B).

The generally rectangular channel 142 extends the longitudinal length ofthe housing 140, terminating at one end of the housing 140 at an openingdefined by a first end surface 144 (see FIG. 13A) and terminating at theopposing end of the housing 140 at an opening defined by a second endsurface 145 (see FIG. 5). The first and second end surfaces 144, 145 ofthe housing 140 have a contoured shape. In the example shown, andreferring to FIGS. 5, 6, and 9A, the coupling element 93 defines a firstcoupling surface 148 extending between the central portion 103 and thefirst end 91, and a second coupling surface 149 extending between thecentral portion 103 and the second end 92 of the coupling element 93. Asshown in FIGS. 7 and 9A, the first end surface 144 of the housing 140and the first coupling surface 148 of the coupling element 93 are eachcontoured such that the surfaces 144, 148 have corresponding contouredshapes and are immediately adjacent each other when the housing assembly150 is attached to the coupling assembly 190. Similarly, the second endsurface 145 of the housing 140 and the second coupling surface 149 ofthe coupling element 93 are each contoured such that the surfaces 145,149 have corresponding contoured shapes and are immediately adjacenteach other when the housing assembly 150 is attached to the couplingassembly 190. The respective contoured shape of each of the surfaces144, 145, 148, 149 is such that the contoured shapes facilitatealignment of the housing assembly 150 to the coupling assembly 190during attachment of the housing assembly 150 to the coupling assembly190. When the housing assembly 150 is attached to the coupling assembly190, the contoured surfaces 144, 148 are immediately adjacent each otherand the contoured surfaces 145, 149 are immediately adjacent each othersuch that the space between the adjacent surfaces 144, 148 is minimaland/or the adjacent surfaces 144, 148 contact each other, and such thatthe space between the adjacent surfaces 145, 149 is minimal and/or theadjacent surfaces 145, 149 contact each other, to constrain and/orprevent axial movement of the housing assembly 150 relative to thecoupling assembly 190 when the housing assembly 150 is attached to thecoupling assembly 190, and to axially align the sensing device 30 to thesensor plug 120, and more specifically, to axially align each of theports 107A, 107B defined by a bridge portion 181 (see FIG. 13A) of thehousing 140 with a respective one of the membranes 126A, 126B of thesensor plug 120 inserted in the plug aperture 155 of the couplingelement 93.

The housing assembly 150 is removably attached to the coupling element93 via a pair of first attachment elements 151 defined by side walls 158of the housing 140 which are attachable to a pair of second attachmentelements 102 defined by the coupling element 93. In the non-limitingexample shown, the first attachment element 151 is configured as a slot,and may be referred to herein as a slot 151. The second attachmentelement, by way of non-limiting example, the configured as a rib, andmay be referred to as a rib 102. The slots 151 are positioned on theopposing side walls 158 defining the channel 142, and the ribs 102 arepositioned on opposing sides of the central portion 103 of the couplingelement 93, such that the housing assembly 150 can be slid over thecentral portion 103 of the coupling element 93 and snapped into place byengaging the slots 151 to the ribs 102, to attach the housing assembly150 to the coupling assembly 190 and to align the bridge portion 181 ofthe housing 140 to the sensor plug 120 and the aperture face 154.Likewise, the housing assembly 150 is readily removable from thecoupling assembly 190 by exerting a pull force on the housing assembly150 to disengage the ribs 102 from the slots 151. For example, thehousing assembly 140 from the coupling assembly 190 when replacing thebattery 77 (see FIGS. 12B, 12C and 13E) in the housing assembly 150,then re-engaged to the coupling assembly 190 for further use. The ribs102 extend substantially along the longitudinal length of the centralportion 103, such that each rib 102 is parallel to the longitudinal axis117 of the coupling device 90. The slots 151 extend substantially alongthe longitudinal length of the housing 140, such that each slot 151 isparallel to the longitudinal axis 117 of the coupling device 90. Theengagement of the ribs 102 and the slots 151 positively positions andlongitudinally aligns the housing assembly 150 relative to the couplingassembly 190 to positively position and longitudinally align the bridgeportion 181 including ports 107 to the sensor plug 120 and the apertureface 154.

As shown in FIG. 10B, each rib 102 is offset from the aperture face 154by a rib offset distance R. As shown FIGS. 13B and 13C, the bridgeportion 181 of the housing 140, in the example shown, includes a pair ofports 107, each defining an interior port end 108 terminating at a portend face 152. Each slot 151 is offset from the end face 152 by a slotoffset distance S. The rib offset distance R and the slot offsetdistance S are configured such that in the installed position, e.g.,with the housing assembly 150 attached to the coupling assembly 190, theport end face 152 of each respective port 107 is in contact with arespective membrane 126 at an engagement depth E (see FIG. 9A) which isgreater than the depth X of an exterior orifice 157 partially defined bythe membrane 126 (see FIG. 11D), such that the port end face 152 incontact with the membrane 126 exerts a stretching force, e.g., apre-tensioning force, on the membrane 126, increasing the tautness ofthe membrane 126 and forming a sealed port chamber 106 (see FIGS. 9A and9B) defined by the port 107, the membrane 126 and a sensor 79 disposedin the port 107. In the example shown in FIGS. 9A and 9B, a sealingelement 88, such as an O-ring, is interposed between the sensor 79 andthe port 107 to seal the sealed port chamber 106. The amount, e.g., themagnitude, of pre-tensioning force exerted by the port end face 152 onthe membrane 126 is determined by the configuration of the port 107 andthe difference between the engagement depth E and the orifice depth X.In the non-limiting example shown, the difference between the engagementdepth E and the orifice depth X is defined by the position of theinterior port end 108 of the housing 140 relative to position of themembrane 126 and sensor plug 120 in the coupling element 93, which isdetermined by the attachment of the ribs 102 and slots 151.

As described in further detail herein, the second membrane 126B exerts amembrane force FM on the actuator 74, where the magnitude of themembrane force FM is defined at least partially by the magnitude of thepre-tensioning force exerted by the port end face 152 on the secondmembrane 126B. It would be understood that increasing the magnitude ofthe pre-tensioning force exerted on the second membrane 126B increasesthe tautness of the membrane 126B and decreases the compliance of themembrane 126B, thereby increasing the magnitude of the membrane force FMexerted by the second membrane 126B on the actuator 74. The membraneforce FM is transmitted via the actuator 74 and the intermediate device37 as a resistive force FR exerted on the nipple element 11 via thelever end 69, such that the resistive force FR can be varied by varyingthe pre-tensioning force of the second membrane 126B. In a non-limitingexample, the pre-tensioning force exerted by the port end face 152 onthe second membrane 126B can be varied by adjusting the axial length ofthe interior port end 108 and/or the shape or configuration of the portend face 152, to change the engagement depth E.

In one example, each housing assembly 150 including the sensing device30 is configured with a unique identifier, so that in use the housingassembly 150 can be identifiable to, e.g., assigned to, a singleindividual subject, for use only with that subject and such that datacollected from that housing assembly 150 can be identified with theunique identifier and associated with the individual subject to whomthat housing assembly has been assigned. In this example, the housingassembly 150 is reusable for each of a plurality of evaluation feedingsessions conducted with the assigned subject. The assigned housingassembly 150 is attached to a non-reusable coupling assembly 190 priorto each evaluation feeding session. The non-reusable coupling assembly190, after a single use and exposure to the fluid used for the feedingsession (the infant formula, juice, water, etc. flowing through thepassage 97), is disposed of, and another non-reusable coupling assembly190 is attached to the assigned housing assembly 150 for use with theassigned subject during a subsequent evaluation feeding session.

The unique identifier of the housing assembly 150 may be programmed intothe software of the housing assembly 150, and retrieved wirelessly bythe evaluation software 188 during initial set-up of the evaluationapparatus 100E and assignment of the specific housing assembly 150 to aspecific subject. For each of a plurality of evaluation sessionsconducted with the subject, the same housing assembly 150 is reused,with the device identifier being used to associate data transmitted fromthe housing assembly 150 with the associated subject. The arrangement ofthe ribs 102 and the slots 151 provides ready removal and replacement ofthe coupling assembly 190 from the housing assembly 150 in use. Insteadof or in addition to programming the unique identifier into the softwareof the housing assembly 150, the unique identifier of the housingassembly 150 may be displayed on a label affixed to or otherwise markedon the housing assembly 150, in alpha-numeric characters and/or in barcode format, for example, and manually inputted and/or scanned into theevaluation software 188 for assignment of that identifier and housingassembly 150 to the respective subject. In one example, the uniqueidentifier may be programmed into one of the boards 104, 146 and/orprinted, etched or otherwise displayed on one of the boards 104, 146.

The coupling device 90 may include one or more orientating features tofacilitate attachment of the housing assembly 150 to the couplingassembly 190 in the proper orientation. In the example shown, thehousing assembly 150 includes a housing orienting feature 131 configuredas a first arrow, and the coupling element 93 includes a couplingorienting feature 133 configured as a second arrow, such that when thearrow 131 and the arrow 133 are pointing at each other, the housingassembly 150 is properly oriented to the coupling assembly 190. Theexample shown is non-limiting and it would be understood that othertypes and configurations of orienting features 131, 133 could be used,including features of asymmetry, for example, in the contoured housingsurfaces 144, 145, and the contoured coupling surfaces 148, 149, etc. toensure proper orientation of the housing assembly 150 to the couplingassembly 190 during attachment of the housing assembly 150 to thecoupling assembly 190.

As shown in detail in FIGS. 10A-10F, the coupling element 93 includes areceiver 96 to receive the intermediate device 37. The intermediatedevice 37 is configured as a lever disposed in the fluid passage 97defined by the coupling element 93, and is pivotably attachable to thereceiver 96. In the non-limiting example shown, the intermediate device37, e.g., the lever, includes a lever bar 68 defining the lever end 69at one end and a tail 67 at the opposing end, the tail 67 termination ata tail end 195 (see FIG. 6). The intermediate device 37 includes a pivotelement 99, which in the example shown is configured as a pivot pin andmay also be referred to herein as a pivot pin or a cross-pin 99. In anon-limiting example, the pivot pin 99 is transverse to the lever bar 68and disposed between the tail 67 and the remainder of the lever bar 68.The tail 67 and the pivot pin 99 collectively define the holder 39 ofthe intermediate device 37 which is received into the receiver 96 toposition the intermediate device 37 in the fluid passage 97 relative tothe coupling element 93 and relative to the sensor plug 120. Whenpivotally attached to the receiver 96, the lever end 69 extends out fromthe second opening 169 of the fluid passage 97, such that the lever end69 is positioned in the nipple cavity 19 as shown in FIG. 7. Thereceiver 96 includes the fulcrum 166 and the tail slot 167. In theexample shown, the fulcrum 166 is configured as a generally cylindricalrecess which is sufficiently open along its length, e.g., transverse tothe longitudinal axis 117, to receive the pivot pin 99, such that thepivot pin 99 may be snapped into the cylindrical recess 166 to retainthe pivot pin 99 in the cylindrical recess, e.g., in the fulcrum 166,preventing axial movement of the intermediate device 37 relative to thelongitudinal axis 117, while allowing the pivot pin 99 and the lever bar96 to pivot freely in the cylindrical recess 99, e.g., in the fulcrum 99about a pivot point PP. When the pivot pin 99 is pivotally attached tothe fulcrum 166, the tail 67 of the intermediate device 37 is positionedin the tail slot 167 defined by the receiver 96, as shown in FIGS. 10Dand 10F. The tail slot 167 is configured to allow the tail 67 to pivotduring pivoting of the intermediate device 37, yet is configured toprevent twisting or side to side movement of the tail 67 relative to thelongitudinal axis 117. The example of a pivot element 99 configured as apivot pin and a fulcrum 166 configured as a generally cylindrical recessdefined by the receiver 96 is non-limiting, and it would be understoodthat the pivot element 99 and the fulcrum 166 may be shaped and/orconfigured otherwise to position the intermediate device 37 relative tothe receiver 96 such that the intermediate device 37 is pivotable aboutthe pivot point PP. For example, the pivot element 99 and the fulcrum166 may be shaped and/or configured to collectively define a pivot jointsuch as a ball and socket joint, a saddle joint, a hinge joint, acondyloid joint, a cylindrical joint, a revolute joint, etc., such thatthe intermediate device 37 is pivotable about the pivot point PP. In anon-limiting example, the pivot element 99 may be located at the tailend 195 such that the tail end 195 is located in the fulcrum 166, andthe intermediate device 37 is pivotable about a pivot point PP locatedat the tail end 195.

The lever bar 68 including the lever end 69 is substantially rigid suchthat the lever bar 68 does not bend in response to the deformation forceFT applied to the lever end 69, to provide for direct motion transferfrom the nipple 11 to the membrane 126B via the actuator post 74. In oneexample, the intermediate device 37 is an integral member formed of apolymeric FDA Class VI “food safe” material. In one example, theintermediate device 37 is made of thermoplastic polymer, which, by wayof non-limiting example, may be one of USP Class VI acrylonitrilebutadiene styrene (ABS), USP Class VI polypropylene, or the like. Theexamples are non-limiting, for example, the intermediate device 37 couldbe formed of materials having properties consistent with ABS andpolypropylene, such as Cycolac®, VisiJet Flex®, PC-ISO® polycarbonate,and Accura® and like materials used in additive manufacturing.

The intermediate device 37 further includes an actuator 74, which in theexample shown in FIGS. 6-8 is configured as a vertical post 74 extendingfrom the lever bar 68 and terminating in a post end 156. The actuator 74is positioned on the lever 37 intermediate the lever end 69 and the tailend 195, and in the example shown is positioned intermediate the pivotelement 99 and the lever end 69. The actuator 74 may also be referred toherein as the actuator post 74. As shown in FIGS. 6, 7, 10E and 10F, theactuator post 74 is transverse to the lever bar 68 and perpendicular tothe pivot pin 99 such that, when the intermediate device 37 is installedinto the receiver 96, the post end 156 of the actuator post 74 can bepivoted in contact with one of the membranes 126. The post end 156 isgenerally rounded in shape and smooth, such that the post end 156 isslidably movable against the surface of the second membrane 126B suchthat the second membrane 126B stretches and/or is moved in a generallydomed fashion with the impingement of the post end 156 and inward asealed port chamber 106B, and such that the smooth surface of the postend 156 does not scratch or otherwise damage the second membrane 126B.The example of a generally rounded post end 156 is not limiting, andother shapes of the actuator post 74 and/or the post end 156 could beused. For example, the post end 156 could be generally shaped as a dome,button or disk having edges which are rounded, chamfered radiused orotherwise smoothed to provide a slideable interface with the secondmembrane 126B. As shown in FIG. 7, with the nipple element 11 in anon-deformed or resting condition, the intermediate device 37 is pivotedto a resting pivot angle θ_(R), such that the lever end 69 rests incontact with the inner surface 17 of the non-deformed nipple element 11.The lever end 69 in contact with, but detached from, the inner surface17 of the nipple element 11, such that the lever end 69 can bedeflected, e.g., pivoted, by deformation of the nipple element 11between the resting pivot angle θ_(R) and a deflected pivot angle θ_(D).The post end 156 of the actuator post 74 is in sufficient contact withthe second membrane 126B such that any deflection (pivoting) of theintermediate device 37 from the resting condition, e.g., from the pivotangle θ_(R) generates movement of the second membrane 126B, wheremovement of the second membrane 126B is caused (actuated) by pivoting ofthe post end 156 against the interior surface of the second membrane126B. As such, there is no initial “dead zone” or space between the postend 156 and the membrane 126B which must be traversed prior toinitiating movement of the second membrane 126B in response todeflection of the lever end 69 from the resting pivot angle θ_(R).Configuring the evaluation apparatus 100D to eliminate the “dead zone”,e.g., such that the post end 156 is in contact with and/or exerting aminimal contact pressure on the second membrane 126B when the lever end69 is in contact with the inner surface 17 of the non-deformed nippleelement 11 increases the accuracy and precision of the sensing apparatus130 to sense deflection of the lever end 69 in response to deformationof the nipple element 11 from the non-deformed state, since anydeflection of the lever end 69 from the resting pivot angle θ_(R)generates an instantaneous corresponding movement of the second membrane126B, and the positive positioning of the lever end 69 on the nippleinner surface 17 by the biasing force exerted by the post end 156 incontact with the second membrane 126 with the nipple element 11 in anon-deformed condition establishes a baseline from which deflection ofthe lever end 69 and pivoting of the intermediate device 37, e.g., thelever, by deformation of the nipple element 11 by the tongue of asubject during a suck-swallow-breathe sequence can be measured, and/orfrom which the evaluation apparatus 100E can be calibrated.

As shown in FIG. 8, the deformation force FT is transmitted via thelever bar 68 and is exerted as an actuator force FA by the actuator post74 on the second membrane 126B of the sensor plug 120. The secondmembrane 126B exerts a resistive membrane force FM in opposition to theactuator force FA. As shown in FIGS. 7 and 8, pivoting of the lever bar68 with sufficient force to overcome the resistive membrane force FM ofthe second membrane 126B causes the post end 156 to impinge on andstretch the membrane 126B, thereby changing, e.g., decreasing, thevolume of the port chamber 106B adjacent the membrane 126. As shown inFIGS. 7 and 8, pivoting of the lever bar 68 away from the secondmembrane 126B, for example, when the deformation force FT is decreasing,causes the post end 156 to move away from the membrane 126B, therebychanging, e.g., increasing, the volume of the port chamber 106B adjacentthe second membrane 126B. The resistive membrane force FM exerted by thesecond membrane 126B may be varied, for example, by varying the membranethickness MTB (see FIG. 11D) of the second membrane, changing theelasticity of the material comprising the second membrane 126B, changingthe engagement depth E to modify the tautness to which the secondmembrane 126B is stretched, e.g., pre-tensioned, by the port end face152 in contact with the second membrane 126B, etc. thereby changing thecompliance of the second membrane 126B and the resistive membrane forceFM exerted by the second membrane 126B on the actuator post 74.

As shown in FIGS. 7-8, the intermediate device 37 freely pivots in thereceiver 96 such that, when the lever end 69 in contact with the innersurface 17 of the nipple element 11 is deflected by deformation of thenipple element 11, for example, in response to a tongue force FT of asubject applied to the nipple element 11 during a sucking event, theintermediate device 37 is pivoted in the receiver 96 in proportion tothe amount of deflection of the lever end 69 by the tongue force FT. Thelocation of the lever end 69 at any point during a suck-swallow-breathesequence of a sucking event may be expressed in terms of the pivot angleθ. In the example shown in FIGS. 7 and 8, the origin of the pivot angleθ is the pivot point PP defined by the pivot element 99 of intermediatedevice 37 and the fulcrum 166 of the receiver 96, and the lever axis 118of the intermediate device 37. In a non-limiting example, thelongitudinal axis 117 of the coupling device intersects the pivot pointPP and lever axis 118 of the intermediate device 37. In the exampleshown in FIG. 7, the nipple element 11 is in a non-deformed or restingcondition, such that the lever bar 68 is pivoted downward (as shown onthe drawing) away from the longitudinal axis 117 with the lever end 69resting in contact with the non-deformed inner surface 17 of the nippleelement 11 in a resting position corresponding to a resting pivot angleθ_(R) shown in FIG. 7. FIG. 8 shows the lever bar 68 pivoted upward (asshown on the drawing) away from the resting position, to a deflectedposition corresponding to a deflected pivot angle θ_(D). The evaluationapparatus 100E may be calibrated, by way of example, such that theresting pivot angle θ_(R) defines a pivot angle θ of zero degrees, andthe deflected pivot angle θ_(D) is greater than zero degrees, asexpressed relative to the resting angle θ_(R)=0. The lever bar 68 may bepivoted to the deflected position and to the deflected pivot angleθ_(D), by movement of the nipple wall 16 and the inner surface 17 of thenipple element 11 during deformation of the nipple element 11 of thetype shown in FIG. 3, where the magnitude of the deflected pivot angleθ_(D) corresponds to the deformation distance D. It would be understoodthat the deflected pivot angle θ_(D) is variable with the amount ofdeformation of the nipple element, such that the deflected pivot angleθ_(D) varies in proportion to the deformation distance D by movement anddeformation of the nipple wall 16 during a sucking event.

The sensor plug 120 is shown in additional detail in FIGS. 11A through11E. The sensor plug 120 includes a central portion 119 which defines aframe for at least one membrane 126 disposed therein. In the exampleshown, the sensor plug 120 includes first and second membranes 126A and126B. The central portion 119 may be referred to herein as a frameportion 119. The sensor plug 120 includes opposing first and secondflanges 121 and 122 extending outwardly from the frame portion 119. Inthe example shown herein, the first flange may be referred to herein asan exterior flange 121 and the second flange may be referred to hereinas an interior flange 122. As used herein, the term “interior” refers tothe interior of the coupling element 93 including the fluid passage 97,such that, as shown in FIGS. 7 and 8, in an installed position, theinterior flange 122 of the sensor plug 120 is positioned in the interiorof the coupling element 93, e.g., the interior flange 122 is positionedin the fluid passage 97 and is in communication with fluids in the fluidpassage 97. As used herein, the term “exterior” refers to the exteriorof the coupling element 93, such that, as shown in FIGS. 7 and 8, in aninstalled position, the exterior flange 121 is positioned on an exteriorsurface, and in the present example, is positioned on the aperture face154 of the coupling element 93. The terms “interior” and “exterior” arenot intended to be limiting, and it would be understood that otherrelative terms may be used to describe relative sides of the sensor plug120. For example, the second or interior flange 122 may be referred toas being on the “measured” side of the sensor plug 120, such that theenvironment being measured and/or the actuators actuating the membranes126 of the sensor plug 120 are presented to the second flange 122. Thefirst or exterior flange 121 may be referred to as being on the sensorside of the sensor plug 120, such that the sensors 79 for detectingchanges in a condition of the membranes 126 of the sensor plug 120 arepresented to the first flange 121.

In the present example, the coupling element 93, and specifically, theaperture lip 101 of the coupling element 93, extends into a sealinggroove 123 of the sensor plug 120 such that the interior flange 122 isseparated from the exterior flange 121 by the aperture lip 101, and suchthat the measured environment, e.g., the fluid passage 97 and theactuator post 74, are contained by the separating element, e.g., thecoupling element 93, and separated from the sensor side of the sensorplug 120 including the exterior flange 121. The sealing groove 123 ofthe sensor plug 120 extends the perimeter of the sensor plug 120 and isdefined by a groove face 124 and the exterior and interior flanges 121,122. In an installed position, as shown in FIGS. 7 and 8, the grooveface 124 is immediately adjacent to and preferably in contact with theaperture lip 101 of the coupling element 93, the exterior flange 121extends onto and is in contact with the aperture face 154 of thecoupling element 93, and the interior flange 122 extends onto and is incontact with the inner wall surface 95 of the coupling element wall 196immediately adjacent the plug aperture 155, such that the sensor plug120 encloses and seals the plug aperture 155, thereby preventing anyleakage of fluid from the passage 97 via the plug aperture 155. Theinterior flange 122, in the example shown, includes a contoured portion129 at each of the opposing ends of the interior flange 122, where thecontoured portions 129 are contoured to provide continuous contactbetween the interior flange 122 and the rounded inner wall surface 95 ofthe coupling element 93. In the example shown in FIG. 11E, a firstsealing bead 128 extends continuously about the perimeter of the sealinggroove 123 between the groove face 124 and the exterior flange 121, anda second sealing bead 128 extends continuously about the perimeter ofthe sealing groove 123 between the groove face 124 and the interiorflange 122, to enclose and seal the aperture 155.

At least one membrane 126 is positioned within the frame portion 119. Inthe example shown, the sensor plug 120 includes a first membrane 126Aand a second membrane 126B. In the installed position, the firstmembrane 126A is in fluid communication with the fluid passage 97 and isconfigured to move in response to changes in fluid pressure in the fluidpassage 97. Movement of the first membrane 126A is sensed by the firstsensor 79A to provide a measurement of pressure change of the fluid inthe fluid passage 97. In the installed position, the second membrane126B is positioned relative to the receiver 96 and the intermediatedevice 37 such that the post end 156 of the actuator post 74 isproximate to the second membrane 126B. In the example shown, the postend 156 is in contact with the second membrane 126B when theintermediate device 37 is in a resting position, e.g., when intermediatedevice 37 is pivoted to the resting pivot angle θ_(R) such that thelever end 69 is in contact with the inner surface 17 of the nippleelement 11, and the nipple element 11 is in the non-deformed or restingcondition. In the example shown, with the intermediate device 37 in theresting position at the resting pivot angle θ_(R), the post end 156 isin contact with the second membrane 126B such that the second membrane126B exerts a baseline resistive membrane force FM_(B) on the post end156 to bias the intermediate device 37 to the resting position shown inFIG. 7, and such that any dead zone or open space between the post end156 and the second membrane 126B is eliminated. The baseline resistivemembrane force FM_(B) exerted on the post end 156 is transmitted to thelever end 69 such that in the resting condition, the lever end 69 exertsa resistive force defined by the baseline force FM_(B) (see FIG. 7)against the nipple element 11, and such that the initial resistive forceFR which must be overcome by an applied tongue force FT to causedeformation of the nipple element 11 from the resting (non-deformed)condition to deflect the intermediate device 37 from the resting pivotangle θ_(R) is partially defined by the compliance of the nipple element11 and partially defined by the compliance of the second membrane 126Bas a determinant of the baseline resistive membrane force FM_(B), andsuch that, in the configuration shown in FIGS. 4-14, the second membrane126B functions as a compliance element 80. It would be understood thatcharacteristics of the second membrane 126B could be varied to changethe compliance of the second membrane 126B, thereby changing themagnitude of the resistive membrane force FM, exerted by the secondmembrane 126B on the actuator post 74, to change the effective resistiveforce FR exerted against the deformation force FT, e.g., exerted againstthe tongue of the subject during an evaluation session.

As shown in FIG. 11D, each membrane 126 is characterized by a membranethickness MT, and is disposed between the exterior and interior flanges121, 122 to define one exterior orifice 157 and an interior orifice 127.In the non-limiting example shown in 11D, each of the membranes 126A,126B is offset and/or recessed from the exterior surface of the exteriorflange 121 by an orifice depth X, such that an exterior orifice 157 isdefined by each respective membrane 126A, 126B and an annular shoulder125 disposed between the respective membrane 126A, 126B and the exteriorsurface of the exterior flange 121. Likewise, the interior orifice 127is defined by each respective membrane 126A, 126B and an annularshoulder 165 disposed between the respective membrane 126A, 126B and theinterior surface of the interior flange 122, such that each of themembranes 126A, 126B is offset and/or recessed from the surface of theinterior flange 122. The example shown is non-limiting and it would beunderstood that the membrane 126 could be substantially flush with theexterior surface of the exterior flange 121 such that the annularshoulder 125 would be minimally, e.g., such that the orifice depth Xwould be minimal approaching zero. In another example, the membrane 126could be flush with the exterior surface of the exterior flange 121 suchthat the sensor plug 120 does not include an exterior orifice 157 orshoulder 125, such that the orifice depth X would be zero.

In a non-limiting example, the plug 120 including the membranes 126A,126B are made of a FDA Class VI “food safe” (FS) silicone. The exampleis non-limiting, and other FDA Class VI FS materials, such aspolyethylene and rubber-based materials such as urethane, may be used.In the example shown, the sensor plug 120 is compression molded. Otherforming methods, including injection molding, could be used to form thesensor plug 120.

In the example shown, the membranes 126A, 126B have the same membranethickness MT, such that a thickness MTA of the first membrane 126A isequal to the thickness MTB of the second membrane 126B. In anon-limiting example, the membrane thicknesses MTA and MTB are less than0.5 mm. The thicknesses MTA and MTB may be different. For example, thethickness MTB of the second membrane 126B may be greater than thethickness MTA of the first membrane 126A, to decrease the compliance ofthe second membrane 126B for the purpose of increasing the resistivemembrane force FM. It would be desirable to increase the resistivemembrane force FM of the second membrane 126B, for example, to providecoupling assembly 190 having a relatively higher baseline resistance fortherapeutic use in strengthening the tongue of a subject. The thicknessMTA of the first membrane 126A may be less than the thickness MTB of thesecond membrane 126B, for example, to increase the sensitivity of thefirst membrane 126A to changes in the fluid pressure of the fluid in thepassage 97. For example, a relatively thinner first membrane 126A wouldbe relatively more reactive and/or movable in response to changes in thefluid pressure of the fluid in the passage 97.

Referring to FIGS. 7-9B, the actuator post 74 of the intermediate device37 protrudes into the interior orifice 127 partially defined by thesecond membrane 126B such that the post end 156 contacts the secondmembrane 126B with the intermediate device 37 pivoted to the restingpivot angle θ_(R), as shown in FIG. 7. When the lever end 69 of theintermediate device 37 is deflected from the resting pivot angle θ_(R)to a deflected pivot angle θ_(D), for example, by deformation of thenipple element 11 as shown in FIG. 3, the depth to which the actuatorpost 74 protrudes into the second membrane 126B increases, causingmovement of the second membrane 126B as shown in FIG. 8. Sensor 79Bpositioned on the exterior side of the second membrane 126B, e.g.,adjacent the exterior flange 121 and/or the exterior orifice 157, isconfigured to sense the movement of the second membrane 126B and outputa sensor signal, where the sensor signal is indicative of the amount ofmovement. As such, the sensor signal can be calibrated to the movementof the second membrane 126B, the deflection of the intermediate device37 to a deflected pivot angle θ_(D), and the force applied to the leverend 69 to deflect the intermediate 37 to the deflected pivot angleθ_(D), where, when the evaluation apparatus 100D is used with a subject,the force applied to the lever end 69 is the tongue force FT of asubject applied to the nipple element 11 to deform the nipple element,for example, during a suck-swallow-breathe sequence performed by thesubject during a feeding session conducted by a user of the evaluationdevice 100E.

In the non-limiting example shown, the sensor 79B is a pressure sensorin fluid communication with the sealed port chamber 106B partiallydefined by the membrane 126B, the port 107B containing the second sensor79B, the second sensor 79B, and the sealing element 88 disposed betweenthe second sensor 79B and the port 107B. The sealing element 88 may bereferred to herein as a sensor O-ring 88. When the lever end 69 of theintermediate device 37 is deflected from the resting pivot angle θ_(R)to a deflected pivot angle θ_(D), the depth to which the actuator post74 protrudes into the second membrane 126B increases, causing movementof the second membrane 126B as shown in FIG. 8 which decreases theeffective volume of the sealed port chamber 106B, increasing thepressure in the sealed port chamber 106B. In the example shown, thefluid contained in the sealed port chamber 106B is air, although otherfluids including other gases or liquids, could be used. The pressurewithin the sealed port chamber 106 (each of chambers 106A, 106B) mayalso referred to herein as the chamber pressure, to distinguish thepressure sensed in the sealed port chamber 106 from the fluid pressureof the fluid in the passage 97. The pressure sensor 79B senses thechange in chamber pressure in the sealed port chamber 106B, and outputsa pressure signal which corresponds to the change in chamber pressure,and as such corresponds to the movement of the second membrane 126B dueto intrusion of the actuator post 74 by deflection of the lever end 69of the intermediate device 37.

Still referring to FIGS. 7-9B, the first membrane 126A and the interiororifice 127 partially defined by the first membrane 126A is in fluidcommunication with the passage 97 defined by the coupling element 93,such that changes in fluid pressure P of fluid in the passage 97 causemovement of the first membrane 126A. The sensor 79A positioned on theexterior side of the first membrane 126A, e.g., adjacent the exteriorflange 121 and/or the exterior orifice 157, is configured to sense themovement of the first membrane 126A and output a sensor signal, wherethe sensor signal is indicative of the amount of movement of the firstmembrane 126A. As such, the sensor signal can be calibrated to themovement of the first membrane 126A, and the fluid pressure P of thefluid in the passage 97, where, when the evaluation apparatus 100D isused with a subject user, the fluid pressure P of the fluid in thepassage 97 changes with changes in the tongue force FT of a subject userapplied to the nipple element 11 to deform the nipple element, forexample, during a suck-swallow-breathe sequence performed by the subjectuser, where the suck-swallow-breathe sequence will cause changes in thefluid pressure of the fluid in the passage 97. During nutritive sucking(NS), the fluid may include a liquid such as water, infant formula,milk, juice, etc. to be ingested by the subject user and delivered tothe aperture 25 in the nipple element 11 via the passage 97 from abottle container 40 sealably attached to the coupling device 90. Duringnon-nutritive sucking (NNS) the fluid may be a liquid or gas orcombination of these contained in the sealed apparatus chamber definedby the passage 97, the cavity 19 of the nipple element 11, and thecavity 41 of the bottle 40, where the nipple element 11 and the bottle40 are sealably attached to the coupling device 90 to form the sealedapparatus chamber including the passage 97. In the example ofnon-nutritive sucking (NNS), the nipple element 11 may be a pacifierdefining a nipple cavity 19 and sealably attached to the coupling device90.

In the non-limiting example shown, the sensor 79A is a pressure sensorin fluid communication with a sealed port chamber 106A partially definedby the first membrane 126A, the port 107A containing the first sensor79A, the second sensor 79B, and a sensor O-ring 88 disposed between thefirst sensor 79A and the port 107A. When the fluid pressure P of thefluid in the passage 97 changes, the change in fluid pressure P causesmovement of the first membrane 126A. For example, when the fluidpressure P of the fluid in the passage 97 increases, the increasingfluid pressure P increases the tension of the first membrane 126A,causes deflection, e.g., movement and/or stretching of the firstmembrane 126A outward from the passage 97 and into the sealed portchamber 106A, which decreases the effective volume of the sealed portchamber 106A, increasing the chamber pressure in the sealed port chamber106A. In the example shown, the fluid contained in the sealed portchamber 106A is air, although other fluids including other gases orliquids, could be used. The pressure sensor 79A senses the change inchamber pressure in the sealed port chamber 106A, and outputs a pressuresignal which corresponds to the change in the fluid pressure P of thefluid in the passage 97.

As shown in FIGS. 7, 9A and 9B, and in additional detail in FIGS.12A-13E, the sensors 79A and 79B are included in the sensing device 30housed in the housing assembly 150. The sensing device 30 in combinationwith the sensor plug 120 comprises the sensing apparatus 130. Thesensing device 30 is in communication with a communications interfacegenerally indicated at 35 in FIG. 12B, and is electrically connected tothe power source 77 via a connector generally indicated at 29. Thesensing device 30, power source 77 and communications interface 35 areoperably attached to or positioned within the housing 140, which isenclosed by the cover 141 to form the housing assembly 150. The cover141 is generally semi-cylindrical in shape, as shown in FIG. 12B and isattached, in the non-limiting example shown, to the housing 140 with aplurality of cover fasteners 184, which may be screws, pins, etc. In theexample shown, the cover 141 may be hingedly attached to the housing 140by means of one or more hinges 185, such that the cover 141 may behinged open during, for example, replacement of the battery 77, byremoval of one or more of the cover fasteners 184. The cover 141 and thehousing 140 are preferably configured such that the housing assembly 150is a sealed unit. As shown in FIGS. 12B and 12C, the housing 140includes a cover interface 186, which in the non-limiting example isshown is configured as a shoulder or ridge to which the cover 141interfaces to seal the housing assembly 150. The example of attachingthe cover 141 to the housing 140 by cover fasteners 184 is non-limiting,and other configurations of a cover 141 and/or cover interface 186 maybe used. For example, the cover 141 and housing 140 may be formed orshaped such that the cover 141 is removably attachable to the housing140 via a tabbed arrangement, a combination of integrally formed pinsand holes, slots and grooves, etc. without the use of cover fasteners184. The cover 141 and the housing 140 are made of an FDA Class VI “foodsafe” (FS) material. In a non-limiting example, the cover 141 andhousing 140 are each made of a moldable thermoplastic polymer such asUSP Class VI FS acrylonitrile butadiene styrene (ABS) or USP Class VI FSpolypropylene.

The cover 141 includes a window 187 for viewing of a user interfaceelement 75, as shown in FIGS. 7, 12A and 12B. In the non-limitingexample shown, the user interface element 75 is configured as a lightemitting diode (LED) which is operably connected to the communicationsinterface 35 such that the user interface element 75 is viewable througha window 187 defined by the cover 141. The LED may be configured toindicate different colors and to blink at various blink rates includinga constant on or off condition. The window 187 may be sealed, to sealthe cover 141, or may be configured such that when the LED is fitted tothe window 187, the LED sealably interfaces with the window 187 to sealthe cover 141. The communications interface 35 may be programmed toactuate the user interface element 75 to provide light indications to auser of the evaluation apparatus 100E as to the operating status of theevaluation apparatus 100E. For example, the user interface element 75may remain in an unlit or “off” status to indicate the coupling device90 is in one of an immobile condition, has no battery 77 installed, haswoken-up but failed to pair with a mobile device 159 within an allottedtime frame, and/or has timed out after a feeding session of a subjecthas been conducted using the coupling device 90. The mobile device 159,as shown in FIG. 15, includes the tongue evaluation application 188stored to the device memory 178, where the mobile device 159 and thecoupling device 90 have been configured for wireless pairing andcommunication using a wireless protocol such as Bluetooth® Low-Energy,and the tongue evaluation application 188, also referred to herein asthe evaluation application 188, is configured to collect, analyze,transmit and/or store data received wirelessly from the sensingapparatus 130 of the coupling device 90.

By way of non-limiting example, the user interface element 75 maydisplay a first color and blink at a first blinking rate, for example,display red and blink slowly, to indicate the coupling device 90 is“on,” e.g., woken up, but not yet paired with the mobile device 159,and/or the user interface element 75 may return to the first color andfirst blinking rate after a feeding session with a subject has beencompleted and the coupling device 90 has been deactivated from tongueevaluation application 188. The user interface element 75 may display asecond color and a first blinking rate, for example, display green andblink slowly, to indicate the sensing apparatus 130 has paired with theevaluation application 188, and is awaiting user activation, or ispaused during data streaming from the coupling device 90 to the mobiledevice 159. The user interface element 75 may display the second colorand be lit but not blinking, e.g., display green and glow solid, toindicate the feeding session has been initiated by the user, e.g., asubject is being fed by the user using the evaluation apparatus 100E,data is being streamed from the sensing apparatus 130 to the mobiledevice 159 during the feeding session, feeding is resumed from a pausedcondition and/or data streaming is resumed when feeding is resumed. Theuser interface element 75 may display the first color and a secondblinking rate, for example, display red and blink fast, to indicate thecoupling device 90 has moved out of range of the mobile device 159during streaming of data, or streaming of data from the coupling device90 to the mobile device 159 has been otherwise interrupted. The userinterface element 75 may display the first color and be lit but notblinking, e.g., display red and glow solid, to indicate the energysupplied by the power source 77 is low at activation or after feeding,e.g., to indicate the power supplied by the battery 77 is low andreplacement of the battery 77 is required, where a low power supply mayprevent wireless communication and/or data streaming between thecoupling device 90 and the mobile device 159. The examples providedherein are illustrative and non-limiting, and it would be understoodthat other light configurations, color and blink rate combinations,etc., may be used as light indications of the various operating statesand conditions of the coupling device 90. For example, the userinterface element 75 may be configured to provide a light indication,using a combination of color and blink rate, to indicate the evaluationapparatus 100E is off tilt, e.g., off center, to alert the user to tiltthe evaluation apparatus 100E, as shown in FIG. 14, to reestablish theorientation of the evaluation apparatus 100E at a predetermined targettilt angle β_(target). The user interface element 75 and window 187 maybe otherwise configured. For example, the user interface element 75 maybe configured to include a display capable of displaying graphicalimages and/or alpha-numeric text to a user to indicate the variousoperating states and conditions of the coupling device 90 and/or todisplay other information such as a device identifier unique to thatspecific coupling device 90 to identify the coupling device 90 ascorresponding and/or being assigned to a specific subject. The deviceidentifier may be, for example, a serial number or a scannable bar codeof the specific coupling device 90 which may be displayed by the userinterface element 75 on the coupling device 90 or packaging accompanyingthe coupling device 90, such that the device identifier is retrievablefrom the coupling device 90, for example, for input to the evaluationapplication 188 during pairing of the coupling device 90 with thespecific subject.

Still referring to FIGS. 12A-13E, the housing 140, as describedpreviously, is configured to be removably attached to the centralportion 103 of the coupling element 93, via the slots 151 defined onopposing side walls 158, where the side walls 158 and the bridge portion181 define the channel 142. The housing 140 may be integrally molded toprovide the housing body 140 shown in FIGS. 13A-13D, and in perspectivein FIGS. 12B and 12C. The housing 140 includes a bridge portion 181which is intermediate the side walls 158 and is intermediate the firstand second contoured housing surfaces 144, 145. The bridge portion 181includes, in the example shown, a plurality of retaining elements 143configured to receive sensor fasteners 147 to fasten the sensor board104 to the bridge portion 181. The sensor fasteners 147 are insertedinto holes 189 in the sensor board 104 and fastened to the retainingelements 143, where the retaining elements 143 and holes 189 arearranged to position the sensor board 104 relative to the bridge portion181, and specifically to position each of the sensor elements 79A, 79Bmounted to the sensor board 104 relative to the respective ports 107A,107B defined by the bridge portion 181. The housing 140 includes abattery cavity 182 adjacent one of the side walls 158 and a board cavity183 adjacent the other of the side walls 158. In the example shown, thecommunications interface 35, which includes a communications board 146to which various elements are mounted, is positioned in the board cavity183. A board locator 194, which may be integral to the housing 140, maybe positioned in the board cavity 183. In the example shown, the boardlocator defines a slot for receiving the communications board 146 toposition and retain the communications board 146 in the board cavity183.

The battery cavity 182 is configured to receive a battery connector 29and a battery 77. A battery locator 193, which may be integral to thehousing 140, may be positioned in the battery cavity 183, and configuredto position and/or retain battery contacts 136 and/or the battery 77. Inthe example shown, the battery 77 is a coin cell battery, also known asa button battery, which is inserted to the battery contact clip 136 toprovide power to the electronics and/or componentry of thecommunications board 35 and the sensor board 104. A coin cell battery 77of the type shown in FIG. 12C can typically have a shelf life of 5 yearsprior to initial use, and is estimated to provide sufficient power tostream data continuously from the coupling device 90 for approximately21 hours before a battery change, e.g., a replacement coin cell battery77, is required. In the example shown, the coin cell battery 77 powersdata streaming from the communications interface 35 continuously at aselective frequency. In one example, data is streamed using Bluetooth®Low-Energy at 16 Hertz (Hz). In another non-limiting example, data isstreamed using Bluetooth® Low-Energy at 30 Hertz (HZ). The battery 77 isreadily replaced by opening and/or removing the cover 141 to access thebattery 77 for removal and replacement. The battery connector 29includes a battery terminal 138 which is electrically connected to thebattery contact clip 136. The battery terminal 138 is electricallyconnectable to a terminal connector 139, which in the example shown islocated on the communications board 146, to conduct power to thecommunications board 146. The communications board 146 is electricallyconnected to the sensor board by a cable 89, such that power can beprovided from the battery 77 through the communications board 146 andcable 89 to the sensor board 104. The cable 89 includes a plurality ofcircuits, such that the cable 89 is configured to conduct power from thebattery 77 to the sensor board 104, and is configured to transmitsignals from the sensors 79A, 79B to the communications board 146 forwireless transmission, for example, by a communications module 132 to amobile device 159 paired to the coupling device 90. The cable 89 mayinclude other circuits, for example, for control of the LED userinterface 75, for communication with an accelerometer 134 included inthe coupling device 90, etc. The example shown in the figures isnon-limiting, and it would be understood that other types of powersources 77 could be used to provide power to the sensor board 104 andthe communications board 132. For example, the housing assembly 90 maybe adapted to be plugged into a ground source of electricity forrecharging of a rechargeable power cell 77, or to be powered directlyfrom the ground source of electricity, where the ground source ofelectricity may be, for example, an electrical outlet connected to thepower grid, or provided via an intervening device. For example, thehousing assembly 90 may be configured for connection to the mobiledevice 159, via a USB port or the like, such that the power source 77 isprovided via the mobile device 159 and/or is recharged via theconnection with the mobile device 159.

The communications interface 35 includes the communications module 132which is operatively attached to the communications board 146. Thecommunications module 132 is configured as a wireless module fortransmitting data including sensor signals generated by the sensors 79A,79B, to a communications interface 135 of the mobile device 159, asshown in FIG. 15. In a non-limiting example, the communications module132 is configured to transmit data via Low-Energy Bluetooth®, e.g.,Bluetooth 4.0®, Smart Bluetooth®, Bluetooth LE® and similar, to themobile device 159, where the data is received by the communicationsinterface 135 and/or transmitted to the evaluation application 188installed on the mobile device 159. The data may be displayed on themobile device 159 on the display 175 of the mobile device 159 forviewing by a user. The use of Low-Energy Bluetooth® to transmit datawirelessly is advantaged by enabling transmission of substantial amountsof data at very low power consumption, such that the coupling device 90can be powered by a low cost and compact energy source such as the coincell battery 77 for multiple evaluation sessions without having toreplace the coin cell battery 77. Further, the use of thenon-rechargeable coin cell battery 77, which does not require rechargingor access to a ground source of electricity for use, allows for the useof the evaluation apparatus 100E in remote or field locations wherereplacement coin cell batteries 77 can be provided however a groundsource of electricity may not be readily available.

The coupling device 90 may also include the accelerometer 134, which inthe example shown may be electrically connected to the communicationsboard 146. The example is non-limiting, and the accelerometer 134 may belocated elsewhere within the coupling device 90, for example, on thesensor board 104 or in a location within the housing 140 where theaccelerometer 134 can be oriented relative to the housing 150, poweredby the power source 77, and in communication with the communicationsmodule 132 such that data can be transmitted from the accelerometer 134to the communications module 132 and via the communications module 132to the mobile device 159. In one example, the accelerometer 134 is asmall, low-power, 3-axis linear programmable accelerometer such as anXtrinsic® FXLS8471Q accelerometer or the like. The accelerometer 134 isconfigured to detect the apparatus tilt angle β of the evaluationapparatus 100E, where, in a non-limiting example shown in FIG. 14, thetilt angle β measures the orientation of the evaluation apparatus 100Erelative to a horizontal axis 191, including the pitch, yaw and/or rollof the evaluation apparatus 100E relative to the horizontal axis 191.The tilt angle β, in one example, can be measured and output to themobile device 159 for display, as shown in the example display 175illustrated in FIG. 16. In the example shown, a measured or actual tiltangle β_(actual) of the evaluation apparatus 100E can be compared with aminimum or target tilt angle β_(target) which has been established orpredetermined for the evaluation apparatus 100E, and feedback providedto the user to adjust the tilt angle β of the evaluation apparatus 100Efrom the current measured tilt angle β_(actual) to the target tilt angleβ_(target), e.g., in the illustrated example, in the exemplary display175 in FIG. 16, feedback is provided to “tilt upward” the evaluationapparatus 100E to adjust the orientation of the evaluation apparatus100E to the target tilt angle β_(target). The target tilt angleβ_(target) may be determined as the angle required to optimizeorientation of the evaluation apparatus 100E for feeding of the subject,to provide a flow of fluid to the nipple 11, and fluid in the passage 97in contact with the sensor plug 120 and/or plug membranes 126A, 126B insufficient volume to submerge the interior flange 122, filling theinterior orifices 127 of the sensor plug 120 with fluid such that themembranes 126A, 126B are fully covered by the fluid, where completelycovering the membranes 126A, 126B with the volume of non-compressiblefluid optimizes the accuracy of measurements of fluid pressure changeswithin the apparatus chamber defined by the nipple cavity 19, passage 97and bottle cavity 41. In the example shown, the target tilt angleβ_(target), e.g., the minimum preferred tilt angle, is 45 degrees. Theaccelerometer 134 may include auto-awake and return to sleep functions,which may be enabled and/or programmed to save power consumption of thebattery 77 when the evaluation apparatus 100E is not in use and/or isnot transmitting data. The accelerometer 134 may include pulse and/ortap detection which may be programmed for example, such that theevaluation apparatus 100E may be turned “on” and/or woken up by a usertapping the coupling device 90 and/or evaluation apparatus 100E in apredetermined pattern. In one example, the coupling device 90 isprogrammed to wake up in response to a double tap of the coupling device90 by a user.

Referring to FIGS. 12A-12C, in the example shown, the sensor board 104includes first and second sensors 79A and 79B, which are arranged on thesensor board 104 for positioning in the respective first and secondports 107A and 107B to form the respective sealed port chambers 106A,106B when the housing assembly 150 is attached to the coupling assembly190, e.g., when the bridge portion 181 of the housing 140 interfaceswith the sensor plug 120. In the example shown, each of the sensors 79A,79B is configured as a pressure sensor for detecting changes in chamberpressure, respectively, in each of the sealed port chambers 106A, 106Bcaused respectively, by movement of each of the membranes 126A, 126B.Changes in the chamber pressure of the air in the first sealed portchamber 106A sensed by the first pressure sensor 79A are proportional tomovement of the first membrane 126A in response to changes in fluidpressure P of the fluid in the passage 97 in contact with the membrane126A, such that the sensor signals from the first pressure sensor 126Acan be correlated to pressure changes in the fluid pressure P of thefluid in the passage 97 during a feeding session and corresponding tochanges in pressure during suck-swallow-breathe (SSB) cycles occurringduring the feeding session. Changes in the pressure of the air in thesecond sealed port chamber 106B, e.g., the chamber pressure, sensed bythe second pressure sensor 79B, are proportional to movement of thesecond membrane 126B in response to the actuation force FA exerted onthe second membrane 126B by the actuator port 74 by deflection of thelever end 69 causing the intermediate device 37 to pivot about the pivotpoint PP, where the pivot angle θ to which the intermediate device 37 ispivoted and the actuation force FA is proportional to the deformationdistance D to which the nipple element is deformed by the tongue forceFT exerted by the tongue of the subject during a feeding session, suchthat the sensor signals from the second pressure sensor 126B can becorrelated to the deformation distance D and to the tongue force FT toquantify tongue strength and coordination of the subject. In the presentexample, the pressure sensors 79A, 79B are capable of measuringpressures in the sealed port chambers 106A, 106B at a resolution of 0.02milli-bar (mbar) and an accuracy of +/−2 mbar, which can be increased toan accuracy of +/−1 mbar with single point calibration/zero offsetting,such that changes in the deflection of the lever end 69 can be sensedwith a resolution of 0.001 mm. The example is non-limiting, and it wouldbe understood that other types of sensors, for example, infrared,electrical, mechanical (force, stress, strain), electromagnetic,optical, and/or acoustic type sensors could be used and/or configured asthe sensor 79 for detecting movement of the respective membrane 126. Thesensor board 104 may include at least one transducer 76 for convertingthe sensor signals received from the sensors 79A, 79B to output signalswhich are provided to the communications interface 35 for output aselectrical data signals to the mobile device 159. A sensor sealingelement 88, which in the present example is an O-ring or similar annularseal, is positioned on each sensor 79A, 79B to seal the sensor 79A, 79Bto the respective port 107A, 107B, as shown in FIGS. 9A and 9B.

The configuration of the bridge portion 181 and the ports 107 is shownin additional detail in FIGS. 13A-13D, and the interface between thebridge portion 181, the ports 107 and the sensor plug 120 when thecoupling assembly 190 is attached to the housing assembly 150 is shownin detail in FIGS. 9A, 9B and 13E. As shown in FIGS. 13A-13D, each portincludes an interior port end 108 protruding from a recessed interiorsurface 153 of the bridge portion 181, and an exterior end 109protruding from the exterior surface of the bridge portion 181. The portchamber 106 defined by each port 107 is tapered from the exterior end109 to the interior end 108, as shown in FIG. 13D, to facilitate sealingof the sensor 79 to the port 107. As shown in FIGS. 9A, 9B and 13E, thesensor O-ring 88 is disposed between the sensor 79 and the inner surfaceof the port 107 defining the port chamber 106, such that the sensorO-ring 88 is compressed between the sensor 79 and the tapered surface byattachment of the sensor board 104 to the retaining elements 143 by thesensor fasteners 147, to seal the port chamber 106 at the exterior end109 of the port 107.

When the coupling assembly 190 is attached to the housing assembly 150by attachment of the ribs 102 to the slots 151, the recessed interiorsurface 153 of the bridge portion 181 interfaces with the sensor plug120 to exert a compressive force on the exterior flange 121 of thesensor plug 120, to seal the sensor plug 120 to the housing 140, and toposition the port end faces 152 of each of the ports 107A, 107B incontact with the respective membranes 126A, 126B at the engagement depthE, as previously described, such that the port end face 152 in contactwith the membrane 126 seals the port chamber 106 at the interior end 108of the port 107.

Referring now to FIG. 15, the tongue evaluation system 105A is shown.The evaluation system 105A and evaluation apparatus 100E can be usedwith a subject in a noninvasive manner to accurately collect, model andquantify the tongue movement, tongue force, and/or sucking behavior of asubject, which may include determining the deformation forces exerted bythe subject on the nipple element 11 during an evaluation feedingsequence, during which the subject may perform one or moresuck-swallow-breathe (SSB) sequences. Both NS and NNS evaluationsessions may be used to evaluate a subject. The evaluation system 105Aincludes the evaluation apparatus 100E, configured in a non-limitingexample as previously described herein. The evaluation apparatus 100E isin communication with the mobile device 159, such that signals, data,information etc. can be transmitted between the evaluation apparatus100E and the mobile device 159. In the example shown, the evaluationapparatus 100E and the mobile device 159 are connected wirelessly viathe wireless communications module 132 in the evaluation apparatus 100E,where the communications module 132 uses low energy Bluetooth® such thatsubstantial amounts of data may be streamed to and from the couplingdevice 90 to the mobile device 159 with minimal power consumption fromthe battery 77.

The mobile device 159 includes the device communications interface 135,the user interface 175 configured to display information including data,analysis results, messages, etc. to a user, a CPU/processor 192 and thememory 178. Each of the device communications interface 135, the userinterface 175, and the CPU/processor 192 may include and/or be inoperative communication with the memory 178, which may be configured asone or more of Read Only Memory (ROM), Random Access Memory (RAM),electrically-erasable programmable read only memory (EEPROM), etc., of asize and speed sufficient for executing the functions performed by therespective communications interface 135, the user interface 175, and theCPU/processor 192, to store and execute applications used in performingthe functions of the evaluation system 105A, including, for example thetongue evaluation application 188, and to store data in one or moredatabases. The collected and/or stored data may be analyzed forevaluation and measurement of the tongue movement and/or tongue force FTexerted by the subject on the instrumented nipple 10 duringsuck-swallow-breathe (SSB) cycles, from which measurements of tonguestrength and coordination such as work performed, impulse, power,sucking frequency, rate of force production, rate of tongue movement,deformation distance, or other strength and coordination measures may bederived. Analysis may include evaluation of sucking frequency and/orrate, rate of exerted force (exerted force measured over time),deformation rate (deformation distance over time) or other parametersmeasured over the time period of the sucking session which may be used,for example, to quantify fatigue. The configuration shown in FIG. 15 isnot intended to be limiting, and it would be understood that functionsperformed by each of the elements 175, 192, 178, 135 may be performed byanother of the elements 175, 192, 178, 135 as configured to do so. Themobile device 159 may be, by way of non-limiting example, a portablecomputer (PC), a laptop, a tablet computer such as an Android™ tablet oran iPAD®, a handheld PC, a personal digital assistant (PDA), a smartphone such as an Android™ phone or an iPhone®, or other small computingdevice, or the like. In the non-limiting example shown, the system 105Ais operated using an Android™ based hardware platform. In a non-limitingexample, the evaluation application 188 which is an Android 4.4 orgreater mobile device software designed to receive and display feedingdata streamed from the housing assembly 150 during use. The evaluationapplication 188 is configured to execute multiple functions includingprovisioning of only authorized mobile devices 159, providing for secureuser login to the evaluation application 188, inputting, manually or bybar code scanning, a subject identifier unique to the subject, providingfor secure lookup and view of past feeding data for a subject, receivingfeeding parameter input such as pacifier or nipple type, bottle type,fluid type, fluid volume, etc. collecting and displaying feeding data inreal-time, using, for example and as shown in FIG. 16, the userinterface 175 of the mobile device 159, and receiving user input andnotations related to the subject and/or feeding session.

By way of non-limiting example, an example of data which may bedisplayed by user interface 175 of the mobile device 159 is shown inFIG. 16. It would be understood that the example shown in FIG. 16 is oneof a plurality of data screens which may be displayed to and/ormanipulated by a user. User manipulation of the data screens mayinclude, for example, selecting a data screen configuration from a menuof available data screens, viewing and/or zooming in or out ofsub-screens such as a lever pressure screen 174 displaying output fromthe second sensor 79B corresponding to pivoting of the intermediatedevice 37, e.g., the lever, by the nipple element 11 and in response tothe applied tongue force FT of the subject, or such as a suctionpressure screen 172 displaying output from the first sensor 79Acorresponding to the change in fluid pressure of the fluid in the fluidpassage 97 of the coupling device 90, selecting and/or viewing aggregatepressure display 176, etc. User manipulation of the data screens mayinclude, for example, starting and stopping feeding timers 171 usingcontrols 173, viewing bottle tilt orientation 180 determined by outputfrom the accelerometer 134 and adjusting the bottle position relative tothe subject as indicated by a tilt alert display 179, monitoring abattery power indicator 177 for indications of a need to change thebattery 77 on the unit, accessing the settings for selection of otherscreens or to perform administrative functions such as identifying thesubject and/or the housing assembly 150 to the evaluation application188, adjusting the screen brightness for viewability or environmentalconditions such as night time feedings, etc. The user display 175 may beconfigured as a touch screen and include an onscreen touch keyboard,such that manipulation and input to the user display 175 and theevaluation application 188 can occur with the need for an externalkeyboard, mouse, etc., for the convenience of the user in manipulatingthe user display 175 while holding an infant subject and/or theevaluation apparatus 100E during an evaluation feeding session. Inanother example, an external keyboard and/or mouse, which may bewireless, may be operatively connected to the mobile device 159 and usedfor data input and display manipulation.

The mobile device 159 is in communication with a web portal 160 eitherdirectly or through a network 170, via the device communicationinterface 135 and a network interface 161 of the web portal 160. Thenetwork 170 may also be known as the Internet. The web portal 160includes the network interface 161, an administrator interface 164configured to display information including data, analysis results,messages, etc. to an administrator, a CPU/processor 162 and a memory163. Each of the network interface 161, the administrator interface 164,and the CPU/processor 162 may include and/or be in operativecommunication with the memory 163, which may be configured as one ormore of Read Only Memory (ROM), Random Access Memory (RAM),electrically-erasable programmable read only memory (EEPROM), etc., of asize and speed sufficient for executing the functions performed by therespective network interface 161, the administrator interface 164, andthe CPU/processor 162, to store and execute applications used inadministering the functions of the evaluation system 105A.Administrative functions performed by the web portal 160 may include,for example, storing and aggregating subject data in one or moredatabases, analyzing and reporting subject data for clinicianinterpretation, administrating protocols for data encryption of datacommunicated, displayed and/or otherwise transferred between the mobiledevice 135, the evaluation apparatus 100E and/or the web portal 160,authenticating users of the evaluation system 105A and the datagenerated by the evaluation system 105A, administering of protocols toprotect and encrypt data for cloud storage of data and/or compliancewith Health Insurance Portability and Accountability Act (HIPPA) privacyrules in the United States and similar regulations in other regions orcountries, and/or otherwise securing the transfer of data using dataencryption protocol such as Secure Hypertext Transfer Protocol (HTTPS),Secure Socket Layer (SSL) and administering related code keys which mayinclude public/private key pairs for securing the web portal 160. Theweb portal 160 administers a database which includes unique identifiersassigned to each of the housing assemblies 150, time-sensitiveprovisioning codes used for temporary security identity during initiallaunch of the evaluation application 188 on a new mobile device 159,login keys identifying the mobile application 188 and each housingassembly 150 to the web portal 160, and pairs a unique subjectidentifier with each unique housing assembly 150.

Referring to FIG. 17, shown is an exemplary method 200 for use by a userto access and utilize the evaluation system 105A, including theevaluation apparatus 100E, to evaluate the tongue movement and tonguestrength and coordination of a subject. At step 202, the user launchesthe evaluation application 188 on a mobile device 159. At step 204, adetermination is made by the evaluation application 188 and/or the webportal 160 in communication with the evaluation application 188, ofwhether the mobile device 159 has been provisioned. If the evaluationapplication 188 has not yet been provisioned to the mobile device 159,the user obtains a provisioning code from the web portal 160, whichassociates the user with the mobile device 159, and/or with mobiledevices 159 in an administrative unit to which the user is authorized.At step 206, the user enters the provisioning code to the evaluationapplication via the mobile device 159, which identifies the provisionedevaluation application 188 as being associated with the mobile device159, thereby provisioning the evaluation application 188 and associatedmobile device 159. On subsequent launches of the provisioned evaluationapplication 188 on the provisioned mobile device 159, the method willproceed directly from step 202 to step 208, with the web portal 160recognizing the evaluation application 188 and the associated mobiledevice 159 as a single entity.

At step 208, the evaluation application 188 determines if the user hasbeen authenticated. If the user has already been authenticated, forexample, has already logged into the evaluation application 188, themethod proceeds to step 212. If the user has not been authenticated, themethod proceeds to step 210 and a login ID and passcode is requested bythe evaluation application 188. The login ID and passcode credentialsare provided to the user by an administrator, for example, from the webportal 160. After authentication of the user, the method proceeds tostep 212, where the user selects the subject from a list displayed tothe user by the evaluation application 188, a menu, by inputting thesubject's identification information or otherwise. The evaluationapplication 188 at step 214 determined whether the subject is a newsubject, e.g., has not been previously inputted to the system 105A. Ifthe subject has already been entered into the system 105A, the methodproceeds to step 222. Otherwise, the method proceeds to step 216, andthe user enters the subject's data into the evaluation application 188,where the subject's data may include, for example, a subject identifier,which may be the subject's name, a patient number, or the like, thesubject's age, weight, or other characteristics of the subject. At step218, it is determined whether the housing assembly 150 including asensing device 30 has already been paired to the new subject. If so, themethod continues to step 222. Otherwise, the method continues to step220, and the user pairs a new, e.g., previously unused housing assembly150 including a previously unused sensing device 30 to the patient. Thepairing process includes the housing assembly 150, and morespecifically, the communication module 132 of the housing assembly 150being assigned to the subject, pairing with the evaluation application188 using a unique identifier which is programmed into the communicationmodule 132, e.g., in the present example, the Bluetooth® low energy(BLE) module 132, to establish communications between the housingassembly 150 and the evaluation 188, including enabling the streaming ofdata identifiable to the assigned subject from the housing assembly 150to the evaluation application 188 during an evaluation session. If anindividual housing assembly 150 is attempted to be assigned to more thanone subject, the user is prompted and not authorized to continue until anew (previously unassigned) housing assembly 150 is presented forpairing.

At step 222, subject history, for established subjects, is displayed,which may include a feeding history, data history, etc. Actions for theevaluation session being conducted may also be displayed, includingwhether the evaluation session is to be performed as a nutritive (NS) ornon-nutritive (NNS) session, if nutritive, the type and quantity offluid to be provided, the length of time feeding data should becollected, etc., the type of nipple element 11 to be used, the type ofcoupling assembly 190 to be used, for example, if the compliance of thesecond membrane 126B is being specified for the session, etc. At step224, the user is prompted to edit the subject's information, which mayinclude, for example, updating the subject's weight or updating otherhealth or general characteristics of the subject.

At step 226, the user begins feeding the subject, where the term feedingis non-limiting and can refer to a nutritive or non-nutritive evaluationsession as directed by the instructions provided at step 222. In anutritive feeding evaluation session, the user assembles the evaluationapparatus 100E including a nipple element 11 having an aperture 25through which the subject can ingest nutritive fluid which the userprovides to the container 40 in sufficient quantity to ensure the sensorplug 120 remains fully immersed in fluid for the duration of the feedingsession, before attaching the container 40 to the coupling device 90. Ina non-nutritive feeding evaluation session, the user assembles theevaluation apparatus 100E including a nipple element 11 which may be apacifier or other non-nutritive nipple type, and provides a fluid to thecontainer 40 in sufficient quantity to ensure the sensor plug 120remains fully immersed in fluid for the duration of the feeding session,before attaching the container 40 to the coupling device 90. When thefeeding session is completed, the method continues to step 240 and thesubject's history, which may include additional data from the currentfeeding evaluation session, is reviewed. At step 240, the user maylogout from the evaluation application 188 and the system 105A,indicating the end of the feeding session. The subject's data and filehistory including data transmitted during the current feeding evaluationsession from the assigned housing assembly 150 to the evaluationapplication 188 and stored, for example, on the memory 178 of the mobiledevice 159 may be transmitted to the web portal 160 via the network 170for storage, analyzing, review by a clinician/administrator forrecommendation of a subsequent action plan, etc. when a networkconnection to the network 170 is next established by the mobile device159. An active connection between the mobile device 159 and network 170is not needed to perform data collection during a feeding evaluationsession.

At the beginning of feeding at step 226, the evaluation application 188at step 228 gathers pre-information from the housing assembly 150 whichmay include, for example, the battery voltage, accelerometerorientation, etc. The pre-information may include, for example, scanningan identifier bar code of the housing assembly 150 and/or entering itmanually to the evaluation application 188 to ensure the housingassembly 150 being used for the feeding session is assigned to thesubject being fed. At step 230, the evaluation application 188 receivesfeeding data from the sensing device 30 in the housing assembly 150,which is transmitted wireless via the communications module 132 to theevaluation application 188. The feeding data includes, for example, aseries of number values representing pressure sensor readings from eachof the first and second pressure sensors 79A, 79B, which may bedisplayed as shown, respectively, in data displays 172, 174 on the userinterface 175 of the mobile device 159.

At optional step 232, the feeding may be paused, for example, to addfluid to the evaluation apparatus 100E, to burp the infant subject, etc.The user may provide an input to the evaluation application 188, toindicate the feeding is paused and the evaluation session is not yetcompleted. While feeding is paused, for example, at step 234, the nippleelement 11 may be changed, to provide a nipple element 11 of a differenttype and/or having a different compliance thereby changing the resistiveforce exerted by the nipple element 11 against the tongue of thesubject. The nipple element 11 may be changed to another nipple element11 to change the compliance, for example, if required to decrease thecompliance for a subject with relatively less tongue strength andcoordination, to enable continued feeding. In another example, thenipple element 11 may be changed to another nipple element 11 toincrease the compliance, thereby increasing the resistive force FRexerted against the tongue of the subject, for therapeutic reasons, forexample, to exercise and/or strengthen the tongue. If the nipple ischanged at step 234, the method proceeds to step 236 where the change innipple element 11 is recorded, and feeding at step 230 is recommenced.When feeding is paused at step 232 to terminate the feeding evaluationsession, the method proceeds to step 238, where post session metrics aregathered by the evaluation application 188 and/or input to theevaluation application 188 by the user. Post session metrics mayinclude, for example, the battery charge remaining at the end of thesession, the amount of fluid consumed by the subject during the session,notes and/or observations made of the subject's condition, etc. Thesession for that subject then terminates, and the evaluation applicationmay, for example, return to display the patient selection menu at step212 in preparation for a subsequent session.

An intervention method is described in U.S. non-provisional applicationSer. No. 13/479,640 filed May 24, 2012 and issued as U.S. Pat. No.8,663,131, incorporated herein in its entirety. In the interventionmethod, the compliance of the nipple element 11, and/or the complianceof a compliance element 80 having a known compliance may be used toevaluate and/or to therapeutically develop a subject's tongue strengthand coordination. As previously described herein and applied to theintervention method described in U.S. Pat. No. 8,663,131, sensor plugs120 having a second membrane 126B of known compliance can be usedtherapeutically with the evaluation apparatus 100E, where variouscoupling assemblies 190 having sensor plugs 120 of different, e.g.,graduated, compliance, and could be used in a sequence to graduallyincrease the resistance force FR exerted by the lever end 69 on thetongue facing portion 21 of the nipple element 11, by increasing theresistive membrane force FM component of the effective resistance forceFR, for the purpose of exercising the subject's tongue and increasingthe tongue strength and coordination and deformation force FT exerted bythe tongue of the subject.

The examples provided herein are non-limiting, and it would beunderstood that other configurations of the sensing apparatus 130,sensing device 30, sensor plug 120, intermediate device 37, couplingdevice 90, etc. could be used to provide the functions and execute themethods described herein. It would be understood that the housing 140 orportions thereof such as the bridge portion 181, sensing apparatus 130including the sensing device 30 and the sensor plug 120, theintermediate device 37, and/or the coupling element 93 or portionsthereof such as the central portion 193, individually and/or incombination of one or more of these elements could be used for sensingof various parameters including, by way of non-limiting example,mechanical force, pressure, etc., in applications other than thosedisclosed by the figures. For example, it would be understood that thehousing 140, the sensing apparatus 130 including the sensing device 30,and the sensor plug 120, may be arranged and/or configured such thesensing device 30 is positionable relative to the sensor plug 120 tosense movement of at least one membrane 126 defined by the sensor plug120 by an input causing movement of the at least one membrane 126, suchas a mechanical input or a pressure input, to correlate movement of theat least one membrane 126 to the input.

By way of non-limiting example, the sensing apparatus 130 including thesensing device 30 and plug insert 120 could be configured with one, two,three or more sets of sensors 79, sensor ports 107 and membranes 126, toconcurrently measure one, two, three or more parameters. The sensorapparatus 130 may include at least two sets of sensors 79, sensor ports107 and membranes 126 configured to measure the same parameter, forexample, fluid pressure changes in the fluid passage 97, for comparisonof the sensor outputs and/or to provide an output as an averaged valueof the at least two sets. The sensing apparatus 130 including the sensorplug 120 and sensing device 30 may be used with a sensor housingdefining at least one port 107 in applications other than the couplingdevice 90 described herein. Other configurations and/or shapes ofactuators 74 may be used, multiple actuators 74 may be used, and theactuator(s) 74 may be positioned in locations on the lever, other thanthat illustrated in the figures. For example, an actuator 74 may belocated on the tail 67, or positioned on the lever bar 68 closer to thelever end 69. The coupling device 90 may be configured to includemultiple sensing devices interfacing with multiple sensor plugsconnected to the coupling device 90.

The detailed description and the drawings or figures are supportive anddescriptive of the invention, but the scope of the invention is definedsolely by the claims. While some of the best modes and other embodimentsfor carrying out the claimed invention have been described in detail,various alternative designs and embodiments exist for practicing theinvention defined in the appended claims.

The invention claimed is:
 1. A device comprising: a wall defining apassage; the wall defining an aperture in communication with thepassage; a sensor plug enclosing and sealing the aperture; a receiverdisposed in the passage; a lever defining a lever end, a tail end, and apivot point intermediate the lever end and the tail end; wherein thelever is pivotably attached to the receiver at the pivot point; whereindeflection of the lever end causes an actuator defined by the lever toactuate movement of the sensor plug; a housing attachable to the wall;the housing encompassing a port; wherein a sensor is disposed in theport; and wherein, with the housing attached to the wall, the port is incontact with the sensor plug and the sensor is in communication with thesensor plug via the port.
 2. The device of claim 1, wherein the actuatoris in contact with the sensor plug.
 3. The device of claim 1, whereinthe sensor is configured to sense movement of the sensor plug; whereinthe sensor plug is intermediate the sensor and the passage; and whereinthe sensor is configured to generate a sensor output corresponding tothe movement of the sensor plug.
 4. The device of claim 3, wherein thesensor output is correlated to the deflection of the lever end.
 5. Thedevice of claim 1, further comprising: a membrane defined by the sensorplug; wherein the actuator is in contact with the membrane such thatdeflection of the lever end causes movement of the membrane.
 6. Thedevice of claim 1, wherein the actuator is in continuous contact withthe membrane such that the membrane exerts a membrane force on theactuator in opposition to an actuation force exerted by the actuator onthe membrane.
 7. The device of claim 6, further comprising: a passageopening in communication with the passage and defined by the wall;wherein the lever end extends out of the passage via the passageopening.
 8. The device of claim 7, further comprising: a couplingelement comprising a coupling end and the wall; wherein the coupling endis configured to receive a nipple element such that the passage is influid communication via the passage opening with a nipple cavity definedby the nipple element.
 9. The device of claim 8, wherein the lever endextends into the nipple cavity such that the lever end is detached fromand in contact with a nipple surface defining the nipple cavity.
 10. Thedevice of claim 9, wherein the lever end is deflectable by deformationof the nipple element to pivot the actuator relative to the membrane bya pivot angle.
 11. The device of claim 10, wherein the deformation ofthe nipple element exerts a deformation force on the lever end via thenipple element; wherein the actuation force exerted by the actuatorpivoted by the pivot angle corresponds to the deformation force.
 12. Thedevice of claim 10, where the membrane exerts the membrane force inresistance to the deformation force.
 13. The device of claim 1, wherein:the port, the sensor and the membrane define a sealed chamber; thesensor is a pressure sensor in communication with the sealed chamber tosense a change in a chamber pressure of the sealed chamber; and thechange in chamber pressure corresponds to the movement of the membraneby the actuator.
 14. The device of claim 1, wherein the housing isremovably attachable to the wall.
 15. The device of claim 1, wherein thereceiver is integral to the wall.
 16. The device of claim 1, furthercomprising: a fulcrum defined by the receiver; the fulcrum defining thepivot point; and wherein the lever defines a pivot element which ispivotably attached to the fulcrum at the pivot point.
 17. The device ofclaim 1, wherein the actuator is intermediate the lever end and the tailend.
 18. The device of claim 1, wherein the actuator is intermediate thepivot point and the lever end.